AT-121: A Promising Alternative to Opioid Pain Medications

By Eric Sarlin, M.Ed., M.A.
NIDA Notes Contributing Writer
National Institute on Drug Abuse

Dr. Eric Sarlin’s recent research reveals an experimental compound with a dual action at two opioid receptors which may provide powerful pain relief without many of the usual harmful opioid side effects. The compound may also have potential as a treatment for opioid addiction.

The reason AT-121 is promising is because it provides pain relief without producing the side-effect of euphoria.

This is a novel compound representing potential advancement toward the goal of non-addictive pain medications that are at least as effective as opioids but without typical opioid liabilities. The new compound—called AT-121—may also have potential as a treatment alternative for opioid addiction. Most of the potent analgesics currently in use act through mu-opioid receptors. AT-121 seems to relieve pain in monkeys without causing physical dependence. Most pain medications work by activating a receptor in the neurons the mu-opiate receptor. Mei-Chuan Ko, a professor of physiology and pharmacology at the Wake Forest School of Medicine, says “Oxycodone, morphine, fentanyl, heroin—they all work through the mu-receptor.” Ko is one of the authors of the study.

Dr. Nurulain Zaveri and colleages at Astraea Therapeutics, manufacturer of AT-121, used medicinal chemistry, computer modeling, and structure-based drug design to create and develop AT-121. Like opioids—such as morphine and oxycodone—AT-121 also binds to the mu-opioid receptor. Unlike those opioids, AT-121 also binds to another opioid receptor called the nociceptin/orphanin FQ peptide receptor. According to Dr. Zaveri, this interaction with the NOP receptor enhances AT-121’s analgesic effect and blocks unwanted side effects often seen with current opioid medications.

References

NIDA. (February 12, 2019). “A Promising Alternative to Opioid Pain Medications.”

Prenatal and Early Childhood Brain Development in Mom’s Using Drugs

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From the blog of Dr. Nora Volkow
Director, National Institute on Drug Abuse
March 11, 2019

The National Institutes of Health HEAL (Helping to End Addiction Long-Term) Initiative, which was launched last April, will support a wide range of studies aimed at improving prevention and treatment strategies for opioid use disorder and pain, including efforts to enhance treatments for infants born with Neonatal Abstinence Syndrome/Neonatal Opioid Withdrawal Syndrome. Specifically, HEAL funds will help support an ambitious longitudinal study—The HEALthy Brain and Child Development (HBCD) Study—co-funded by NIDA and several other NIH institutes and offices, to better understand the impact of early exposure to opioids, other substances, and social stressors on brain development in children.

The HBCD study will follow a large population of children from the prenatal period to age 10 and utilize some of the same assessment methods and imaging technologies used in the 10-year Adolescent Brain Cognitive Behavior (ABCD) study. HBCD is expected to enroll women during their second trimester of pregnancy or after birth of their baby. The study will gather data on potentially important factors about their environment, including drug and alcohol use, and follow them and their children over the subsequent decade.

The potential fruits of a longitudinal cohort study of this magnitude will include much new knowledge about the effects of opioids and other substance exposures during fetal development.  It will also yield a better understanding of the effects of genes that are driving brain development. The study additionally will look at many other exposures, including social interactions, environmental toxins, nutrition, and physical activity. Medicine has thus far lacked detailed baseline standards of normative brain development in childhood, and HBCD will help produce such standards. The information gained from the study will create an invaluable reference for pediatricians, pediatric neurologists, and psychiatrists.

The ABCD study recently accomplished its baseline recruitment of close to 12,000 nine- and ten-year-olds, and already the data gathered from the initial neuro-imaging is yielding interesting findings, such as associations between neuro-development and screen time. Likewise, the HBCD study will gather a rich data set that will be freely available to the wider research community to answer a wide range of research questions. For example, researchers can use the data to investigate how the human brain develops and characteristics that might be associated with the early manifestations of brain diseases, as well as those [with an] underlying resilience to adverse environments. As the data are being collected, they will be released so that discoveries can start well before the completion of these 10-year prospective studies. 

As with ABCD, the HBCD study will have multiple research sites across the country to ensure the study population is representative of the larger population, including all ethnic groups and demographics and even including women who use opioids. Exposure to many substances in the womb or through breast milk may have significant developmental consequences, and a study of this magnitude will greatly clarify the effects of prenatal and early opioid exposure on children. It will also greatly increase our understanding of the developmental consequences of environmental stressors like neglect, abuse, economic uncertainty, and the influence of parental opioid and other drug use during the post-natal period.

As you might imagine, there are many potential challenges to conducting regular brain imaging on young children—being able to remain still in MRI scanners is just one of them. There are also special legal and ethical challenges involved in recruiting and studying opioid-using mothers. In September and October of last year, NIDA in partnership with other NIH Institutes and Centers, hosted two expert panel meetings to discuss, respectively, the methodological challenges of studying neuro-development in children and recruitment and retention of high-risk populations in the study, including bio-ethical questions.

Based on input received during these expert panel meeting, it was determined that before soliciting grant proposals for the HBCD study per se, an initial planning period would be necessary. Thus, NIDA along with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Child Health and Human Development (NICHD), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Minority Health and Health Disparities (NIMHD), the Office of Research on Women’s Health (ORWH), and the Office of Behavioral and Social Sciences Research (OBSSR) issued two funding opportunity announcements, one for individual research sites and one for linked, collaborative applications.

The planning grants will be awarded for a period of 18 months, during which time we expect to determine many critical facets of the experimental design. These include how to conduct neuro-imaging in prenatal and early postnatal stages, how to address the legal challenges associated with recruiting opioid- (and other drug-) using participants (which vary by state), how to form partnerships with state agencies and substance use treatment programs, how to retain the mothers in the study, and other practical and ethical issues. Applications are due in the last week of March, 2019. Researchers interested in applying for one of these grants can find more information on RFA-DA-19-029 and RFA-DA-19-036 from grants.nih.gov.

It is a very exciting time for all the sciences that study child health, human development, and the roots of mental health and psychiatric and neurological illnesses. We now have the tools to characterize human brain development in the transition from infancy into adulthood, a time when many of the medical conditions that afflict us later in life originate. The data from the HBCD study will ultimately lead to scientific solutions to addiction, pointing the way to new prevention and treatment interventions and thereby reducing the impact of opioid and other substance use disorders on American families.

Supporting Our Physicians in Addressing the Opioid Crisis

From the blog of Dr. Lora Volkow dated August 31, 2018

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A recurring theme among addiction researchers and professionals is the so-called treatment gap: under-utilization of effective treatments that could make a serious dent in the opioid crisis and overdose epidemic. Ample evidence shows that when used according to guidelines, the agonist medications methadone and buprenorphine reduce overdose deaths, prevent the spread of diseases like HIV, and enable people to take back their lives. Evidence supporting the effectiveness of extended-release naltrexone is also growing; but whereas naltrexone, an opioid antagonist, can be prescribed by any provider, there are restrictions on who can prescribe methadone and buprenorphine.

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A series of editorials in the July 5, 2018 issue of the New England Journal of Medicine made a strong case for lessening these restrictions on opioid agonists and thereby widening access to treatment with these medications. For historical reasons, methadone can only be obtained in licensed opioid treatment programs, but experimental U.S. programs delivering it through primary care docs have been quite successful, as have other countries’ experiences doing the same thing. Although buprenorphine can be prescribed by primary care physicians, they must first take 8 hours of training and obtain a DEA waiver, and are then only allowed to treat a limited number of patients. Some physicians argue that these restrictions are out of proportion to the real risks of buprenorphine and should be lessened so more people can benefit from this medication.

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Stigma contributes to reluctance to use evidence-supported treatment—both stigma against addicted individuals and stigma against agonist medications, due to the persistent myth that they just substitute a new addiction for an old. This idea reflects a poor understanding of dependence and addiction. Dependence is the body’s normal adaptive response to long-term exposure to a drug. Although people on maintenance treatment are dependent on their medication, so are patients with other chronic illnesses being managed medically, from diabetes to depression to pain to asthma. Addiction, in contrast, involves additional brain changes contributing to the loss of control that causes people to lose their most valued relationships and accomplishments. Opioid-dependent individuals do not get high on therapeutic doses of methadone or buprenorphine, but they are able to function without experiencing debilitating withdrawal symptoms and cravings while the imbalances in their brain circuits gradually normalize.

Treating patients with addiction may be uniquely complex and demanding for several reasons. Patients may have co-morbid medical conditions, including mental illness; thus they may need more time than doctors are reimbursed for by insurers. They may also have pain, and while pain management guidelines have changed to respond to the opioid crisis, those changes have not necessarily made a doctor’s job any easier, since there are currently no alternative medications to treat severe pain that are devoid of dangerous side effects.

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Because of the complexity of Opioid Use Disorder (OUD), providers may find that it is not sufficient to simply dispense a new prescription after a quick consultation. These patients often need ancillary services provided by nurses or other treatment specialists; and in the absence of these extra layers of support, treatment is less likely to be successful, reinforcing physicians’ reluctance to treat these patients at all. In short, physicians are being blamed for causing the opioid epidemic, but thus far they have not been aided in becoming part of the solution.

Medical schools are starting to respond to the opioid crisis by increasing their training in both addiction and pain. For example, as part of its training in adolescent medicine, the University of Massachusetts Medical School has begun providing pediatric residents with the 8-hour training required to obtain a buprenorphine waiver—an idea that is winning increasingly wide support. Physicians in some emergency departments are also initiating overdose survivors on buprenorphine instead of just referring them to treatment. And through its NIDA MedPortal, NIDA provides access to science-based information and resources on OUD and pain to enable physicians to better address these conditions and their interactions, including easy-to-use screening tools to help physicians identify substance misuse or those at risk.

But if physicians are going to assume a bigger role in solving the opioid crisis, healthcare systems must also support them in delivering the kind of care and attention that patients need. Physicians need the tools to treat addiction effectively as well as the added resources (and time) for patients who need more than just a quick consultation and a prescription.

The Opioid Issue: Part 4

Part Four: Taking It to the Streets

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The opioid epidemic doesn’t stay behind closed doors. It’s spilling into public life, spurring crime and homelessness.

The opioid crisis has hit hard in Macomb County, Michigan. Composed of 27 Detroit suburbs, the county has the state’s second-highest opioid-related overdose death rate, more than double the national average. District Court Judge Linda Davis has been on the bench 17 years. She sees the consequences pretty much every day. “When I look at the docket I handle, I’d say 70 percent is addiction-related,” she says, not counting low-level traffic offenses like driving on a suspended license. “We’ve definitely seen a rise in thefts with this opioid surge.”

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Although opioid addiction often starts out legally, recent years have seen a shift toward illegal opioids. It’s an all-to-familiar story: People get hooked on prescription painkillers, often moving on to heroin, which can be cheaper on the street. Since 2011, as prescription opioid overdose deaths leveled off, heroin overdoses started rising. Starting in 2014, illicit fentanyl deaths began spiking upward. Whatever the substance, the cost mounts up fast. So many users resort to theft. They’ll steal from family, friends, acquaintances or strangers. They’ll shoplift, commit fraud, rob pharmacies, break into homes or cars. Even commit armed robbery. And whether or not they’re committing those crimes themselves, their desperate dependency can feed some even worse ones.

Lethal Combination

In 2015, the nation’s homicide rate rose sharply (11 percent) after decades of decline. The uptrend continued in 2016, climbing another 8 percent. Some observers looked for racial reasons for it. There could be one, says Richard Rosenfeld, an emeritus professor of criminology and criminal justice at the University of Missouri-St. Louis. But he thinks there’s more to the story. When Rosenfeld looked into the data, he quickly saw homicides had jumped among several ethnicities—and it was very pronounced among whites.

“The increase is quite abrupt, quite recent and quite large, at levels we hadn’t seen since the early 1990s outside of 9/11,” Rosenfeld says. “The ‘Ferguson Effect’ doesn’t explain that. So what might explain it? The opioid epidemic, for one thing—which crosses racial lines, but is most concentrated among whites. Drug-related homicides rose more than 21 percent in 2015, a rate far higher than other common categories of homicide, which rose between 3 and 5 percent. Rosenfeld said it stands to reason that there’d be a connection between the spikes in opioid use and lethal violence.

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“It’s not opioid use per se that sparks violence, but the markets,” Rosenfeld says. “When disputes arise between sellers or buyers, they can’t be settled by police or courts or the Better Business Bureau. As the number of buyers expands, so does the number of disputes that turn deadly will also go up.”

Just how big a role do opioids play in driving the rise in homicides? That calls for more research, Rosenfeld says. But he sees ample evidence to sound the warning and to call for addressing the root causes. “Policymakers and law enforcement are framing this as a public-health crisis more than as a criminal-justice crisis, and I’m very much in favor of that,” he says. “The bottom line is: If we reduce demand, we reduce crime.”

“We Don’t Want Those People Here!”

Reducing demand for opioids would likely reduce other social pathologies too. Like homelessness. “For those of us who’ve been providing health care to people who are homeless, this is not a new problem,” says Barbara DiPietro, senior policy director for the National Health Care for the Homeless Council. “We’ve been seeing opioid addiction and overdoses for decades.

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“When people are in a spiral and aren’t getting the help they need, oftentimes they lose their jobs and their ability to pay rent. Before you know it, you cycle through family and friends, and you’re in a shelter or on the street.” Of course, not all people who are homeless have addiction issues, but those that do have a harder time getting into treatment once the stability of housing is gone. Living on the street could easily drive anyone to substance abuse. Maybe you started with alcohol, but once you were on the street, you found other things. It’s very hard to get well when you’re homeless.

Federally-qualified health centers provide care to 1.2 million people a year, and the Council provides technical assistance to help improve quality and access. DiPietro says homeless service providers often see clients who never expected to be in this situation. “We see a lot of clients who come from construction work or other hard-physical-labor jobs, who got hurt and got prescriptions for legitimate reasons,” she says. “We see a lot of people who’ve experienced trauma in their lives—child abuse, domestic violence, sexual assault. So they self-medicate to deal with the pain.” And on the street, their problems are much more visible than those of people who engage in their addictive behavior behind closed doors.

“They’re living their private lives in a public space,” DiPietro says. “They’re subject to public scrutiny, arrest and incarceration at a much higher rate. And once you have an incarceration history, it’s hard to get housing assistance or a job again.”

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While more medical facilities and first responders are being equipped with opioid-overdose medications like naloxone (Narcan), that’s just an emergency measure, not a solution. DiPietro says what people struggling with addiction and homelessness need most is stable housing where they can get effective treatment. Health care providers the Council works with can help, but not enough to meet the scale of the problem.

Right now, communities don’t have the capacity desperately needed to get people into treatment. Another big obstacle is the attitude known as NIMBY—Not in My Back Yard. “Everyone believes treatment is important, but no one wants the services near them,” DiPietro says. “When that’s proposed, they rise up in community meetings and say, “We don’t want those people here.”

We’ve simply got to get beyond that attitude.

A Parting Thought

I spent forty years in active addiction. It started simple enough: A case of beer and an ounce of Colombian Gold. Eighteen months later I was serving 3 to 10 in state prison. Drug and alcohol abuse continued throughout parole and into my thirties, forties and early fifties. My drug use ran the gamut, from weed to cocaine to crack to opiates. When I couldn’t get enough oxycodone through doctors, I began stealing it from friends and family. My addiction cost me plenty, yes, but it also cost my children, my two ex wives, my brothers, my sister, and my parents. I lost jobs, cars, apartments, friends and family. I blew every penny I made, bounced checks, embezzeled, fenced stolen goods. I was enslaved to addiction. Not only did my family disown me for nearly two years, my youngest son didn’t talk to me for five years.

It’s not only the family of addicts that can become fed up and turn their backs on their loved ones struggling with addiction; society has become rather fed up and impatient. One of our local television stations airs a nightly feature called “Talkback 16,” where viewers call to voice their grievances, pet peeves, and, yes, an occasional compliment. Several days after a news story aired about plans to build a drug and alcohol treatment center in the Pocono Mountains (Pennsylvania), a viewer called to complain about the plan, adding, “Not in my neighborhood. [Addicts and alcoholics] can’t be trusted. Besides, they did it to themselves.”

Truly, this attitude must change.

 

The Opioid Issue: Part 3

Part Three: A System on the Brink

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Already under tremendous strain from a lack of qualified homes and social support, the American foster care system is staring down its toughest opponent yet: the opioid epidemic. Typically, when a mother or father in active addiction has young dependent children, agencies such as Children and Youth or Child and Family Services will remove the children from their parents. Of course, family court judges nearly always focus on possibly reuniting the children and their parents after they become clean and sober.

Consider the mother of a child who was born addicted to opiates. The court removed the infant from the mother’s care and placed him in foster care. After the mother was able to stay clean for one year and put her life back together, the child was returned to her. Sadly, the mother ultimately relapsed, and the child’s health and welfare were put in jeopardy. He would need to reenter the foster care system, this time with the goal of being adopted permanently. Foster Care CollageAccording to the U.S. Department of Health and Human Services (HHS), nearly half a million children nationwide were living in foster care arrangements in 2016—and that number has been rising for the last four years. One could say the very heart of the nation’s foster system is aching for any sort of relief.

A Century-Old Practice

Since creating a Children’s Bureau in 1912, the U.S. government has played a critical role when parents can no longer care for their minor children due to illness, death, criminal activity and/or substance abuse. That care—provided mainly by individual foster families or relatives, but also through group homes and institutions—has at times extended to other nations, such as the more than 8,000 European refugee children who were fostered in American homes during World War II.

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Though it has successfully kept millions of children fed, clothed, educated, sheltered and safe over the last 106 years, the American foster system hasn’t been foolproof. In 1972, when President Richard Nixon declared a “National Action for Foster Children Week” to recruit more foster families, the system has been highlighted mostly for its deficits: Too few willing foster parents, too many kids, too little funding and support, too hard on the heart for everyone involved.

Margie Nielsen deals with those shortcomings daily. As the director of Foster Care & Adoption Ministries at Louisiana Baptist Children’s Home (LBCH)—a nonprofit ministry founded in 1899, more than a decade before official government foster care was created—Nielsen’s organization is an official partner of the Louisiana Department of Children & Family Services. Certified foster parents run residential “cottages” that each accommodate up to six children between the ages of 5 and 17. LBCH exists to educate, inform, encourage, support, and strengthen current and prospective foster parents.

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While there are many families who clearly are not called to foster, everyone can and should be involved in supporting the families who are. In James 1:27, God’s Word teaches, “Religion that God our Father accepts as pure and faultless is this: to look after orphans and widows in their distress and to keep oneself from being polluted by the world” (NIV). It is our duty as the Body of Christ to help foster families to understand the call God has placed on their lives and to help equip them to answer that call. A joy, yes—but the last few years have greatly expanded the need for people to answer that call.

With opioid addiction soaring to crisis level, it certainly calls for more information to be disseminated. And while drug addiction of any kind affects everyone, the nation’s opioid crisis has upped the ante. The necessity of developing preventive strategies is felt more than before.

Little Victims

While the connection between drug abuse and children needing foster care is nothing new—think heroin in the 1970s, cocaine in the 1980s, and meth in the 1990s—what has changed the game for today’s foster care system has been the sheer percentage of Americans struggling with opioid addiction across all demographics. The cold hard truth: That number staggers at more than two million, according to the American Society of Addiction Medicine, a 60-year-old professional society for treatment providers based in Maryland.

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According to the National Institute of Health, 21 to 29 percent of patients suffering from chronic pain misuse their prescription opioids, and that often puts them on the path to harder drugs; about 80 percent of people who use heroin first abused prescription opioids, Tragically, around 116 people in the United States die from an opioid overdose every day—that’s one death every seven minutestranslating into tens of thousands of dead Americans annually. In fact, the U.S. Centers for Disease Control and Prevention reports more than 200,000 people died from prescription opioid overdoses between 1999 and 2016.

It stands to reason that a significant portion of those people who died, as well as the millions living with addiction, were or are parents of minor children. Indeed, HHS reports 30,000 more children were living in foster homes nationwide in 2015 than in 2012, and substance abuse (including, but not limited to, opioids) was cited as a reason in about one-third of those placements. Drug addiction does not discriminate; sadly, it can hit any family at any time. And often, when it does, children of those struggling with addiction enter the already-pressed foster system.

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Simply put, there are not enough foster homes in the United States to accommodate the burgeoning number of kids needing short- and long-term care. In California, for example, the Los Angeles Times reports the number of available beds in qualified foster homes fell from 22,000 in 2000 to just 9,000 in 2016. Massachusetts had more than 6,100 foster children in 2016, but less than 4,800 foster homes, according to The Boston Globe. Such shortages have led to reports of foster children sleeping in government offices and even hotels around the nation while their social workers scramble to find willing families.

But it’s not just the dearth of available foster parents that concerns child welfare advocates. Though government reports show about one-quarter of all formal foster care placements are with relatives (sometimes called kinship care), the vast majority of foster families are strangers to foster children. According to the National Center for Missing & Exploited Children, 88 percent of the 25,000 children who reported ran away from home in 2017 were in foster care at the time. Many of those runaways become the victims of sex traffickers.

We need to pray that as each day passes these foster children (who have had their tiny world shattered by drug abuse) survive—indeed, thrive—and that they live with hearts full of love and hope. Sadly, the future is yet unclear regarding America’s opiate epidemic. Moreover, we don’t know the full scope of opioid crisis’ on the foster system still has yet to be revealed. These little victims never had the choice to be exposed to the drugs. They can’t Just Say No.

Thousands upon thousands of little Americans are waiting to be seen, helped and healed.

The Opioid Issue: Part 2

Part Two: Collateral Damage

As the nation grapples with opioid’s hold over millions, its smallest victims cry out to be heard, held, and healed. No Child Left Behind is a familiar battle cry. But to foster parents helping to care for children of parents addicted to drugs, those words have nothing to do with a political agenda or advertising campaign. One foster mom reported quietly watching another baby detox from opiates, its high-pitched wails unique with the sound of drug-induced anguish, and whispering, “A whole generation is being lost from the opioid epidemic. A whole generation.”

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That generation—with hundreds of thousands of America’s youngest feeling its physical, mental, and emotional impact, sometimes from the moment of conception—is staring down what doctors call Neonatal Abstinence Syndrome (NAS). The condition is not something that can be cured with a pill. There are so many children growing up without their parents that the long-term ramifications are still unforeseen. The United States has certainly faced its share of social and public health problems over the years, but when it comes to the opioid crisis, child advocates around the country warn, it’s a strange and scary new world.

Agony in the Womb

According to a study released by the University of Minnesota this spring, one baby struggling with NAS is born in America every 15 minutes. Furthermore, almost 90 percent of pregnancies among women struggling with opioid addiction are unintentional. When a woman takes opioids while pregnant—even exactly as a doctor might instruct, according to the March of Dimes—she runs the substantial risk of harming her unborn child.

One Baby Every Half Hour

Prescription painkillers like codeine, fentanyl, hydrocodone, morphine, and oxycodone (as well as the street drug heroin) are all classified as opioids and all negatively affect children in the womb. Common risks of opioid use during pregnancy, the March of Dimes says, include miscarriage, preterm labor, premature birth, birth defects, low birth weight (defined as weighing less than five pounds, eight ounces), and NAS. NAS is its own beast. The completely preventable condition can grip babies with tremors, fever, chills, weight loss, seizures, and even death. Dr. W. David Hager, member of Focus on the Family’s Physicians Resource Council (PRC), believes 55-94% of newborns delivered to women who used opioids in pregnancy suffer from NAS.

Clearly, it is nearly impossible for an unborn child to skate past the consequences of his or her mother’s opioid use, no matter how slight. Yet damage isn’t usually intentional. Instead, Hager says, addiction to opioids reaches far beyond the initial physical pleasure to something much deeper.

It All Adds Up

That’s a familiar story for J. Scott Moody and Wendy Warcholik, a married pair of economists. As the directors of Family Prosperity Institute (FPI), a New Hampshire-based think tank focused on measuring the health of the American family, Moody and Warcholik frequently hear about opioid-related crises—and have watched their own loved ones succumb to substance abuse along the way. Warcholik, for example, grew up in a family fragmented by her parents’ collective five divorces. Of all her siblings, she was the only one to have fully escaped the negative consequences. The others have experienced unemployment, substance abuse, government dependency, low educational attainment, unwed childbirth, and divorce.

FPI has created a family prosperity index—a formula-driven rankings list that measures the strength and prosperity of families and the nation by combining the most important economic and social data into a single number and then ranking those states based on which create the best environment for families to thrive. The index fills in the gaps around other measures like the gross domestic product, assembling all the pieces of the prosperity puzzle into a complete picture of the economy. No other measure takes into consideration both the economic and social choices of people in a state to create a holistic measure of human behavior in the States.

The latest FPI index ranked Utah first and New Mexico last. FPI’s formula calculates things like average welfare utilization, children in married households, religious attendance and infant mortality rate. That last category is most disconcerting because as opioid use has risen, so has infant mortality rate. (The U.S. Centers for Disease Control and Prevention defines that as the death of an infant before his or her first birthday), while the infant mortality rate is the number of infant deaths for every 1,000 live births.

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Between 2010 and 2015 twenty-one states saw an increase in their infant mortality rate. So many states, in fact, that while the national average dropped 16 percent between 2000 and 2015, the last five years only saw a decrease of 1.6 percent. Clearly, if trends continue, the country could see an increase in the infant mortality rate in the near future. Keep in mind that a rising infant mortality rate is typically only found in Third World countries. Besides the physical, emotional and mental cost to America’s children, opioid addiction doesn’t come fiscally cheap, either. For example, in 2015 Ohio paid more than $133 million to care for approximately 2,000 NAS babies born that year.

The True Cost

Interestingly, FPI’s research shows that devout beliefs and behaviors (consistent church attendance, daily prayer, Bible reading, etc.) reduce illicit drug use. The converse holds true as well. Moody says, “It is clear that people in despair who don’t turn to God for help will try to numb their pain some other way, whether it be with drugs or sex. Unfortunately, at least for the last decade, we’ve been seeing more and more people turning to drugs and sex than God. We have to reverse this trend.”

Ultimately, America truly has no idea what the long-term consequences of opioid addiction on our most innocent citizens will be. “We read horrifying stories in New England about parents shooting up their own children just to keep them quiet, or left in a freezing car with their parents passed out in the front seat,” Warcholik says. How far are we, as a society, willing to go in elevating adult desires over the health and well being of our children?

That is a question far beyond the scope of any research team—but one the Church must rise up to help answer.

 

 

The Opioid Issue: Part 1

Part One: Dangerous Prescriptions

The opioid crisis seems to hit everyone, everywhere, regardless of socioeconomic class, geography, age, profession, or religious affiliation. Overdosing on drugs, especially opiates and heroin, is now the most common cause of death for Americans under fifty years of age. I spent forty years embroiled in active addiction. It started innocently with a case of beer, but quickly led to marijuana, cocaine, and inhalants. The longer I struggled, the more hopeless I became. Friends stopped calling me or inviting me to parties. Family felt they could no longer trust me given the hundreds of broken promises and countless runs on their medicine cabinets for opiates. Although I was able to stop drinking and taking street drugs in 2008, I battled with benzodiazepines (Xanax, Ativan) and oxycodone for another eight years. I am blessed presently with nearly two years without taking narcotics.

Opiates in Pill Bottles

This epidemic has reached every corner of the United States. This is the first in a series of blog posts regarding opiate addiction in America. This series will address dangers of opiate prescriptions, collateral damage, impact on the nation’s foster care system, homelessness and addiction, troubling developments in drug rehabilitation, addiction and crime, and a Christian response to the crisis.

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Current medical opinion indicates the reason the U.S. is experiencing a disastrous epidemic of opioid abuse can be summed up in two words: pain avoidance. In the 1990s there was a proliferation of health care professionals trying to address the symptom [of pain] and not so much the underlying causes of the pain a person has. In 2015, opioid-related deaths stole the lives of over 33,000 Americans. To put this number into perspective, this outnumbers fatal car crashes and gun deaths during the same year. According to the federal government, in 2016 the nation mourned close to 64,000 deaths from drug overdoses. Two-thirds of those involved the misuse of opioids. Karl Benzio, M.D., a Christian psychiatrist and member of Focus on the Family’s Physicians Resource Council (PRC), fears the toll could reach 80,000 deaths in 2018.

We wouldn’t be here if opioids weren’t so effective. Americans want something for their pain—regardless of whether that pain is physical, mental, or emotional. We live in a psychologically compromised society that is impatient and entitled, whose citizens feel there should be no pain in life. Accordingly, greater demands have been made on providers to eliminate all pain with medication. The problem is—and I know this all too well firsthand—once a patient gets a taste of the relief, some develop a dependence that leads them down a dark path. Ironically, that path leads only to deeper struggles. For some, the exit will only come in the form of fatal overdoses as opioids shut down the body’s ability to breath.

It is time we start helping patients deal with life’s pain and its root causes head-on, rather than masking it through medication.

How it All Began

Chronic Pain The Silent Condition

The current crisis can be traced back nearly forty years. Medical researcher Hershel Jick and graduate student Jane Porter of Boston University Medical Center analyzed data from patients who had been hospitalized there. Close to 12,000 had received at least one dose of a narcotic pain medication during their stay. Of those, Jick and Porter’s analysis found only four had developed a well-documented addiction. Jick sent the findings to the New England Journal of Medicine, who published his analysis as a letter to the editor in 1980. “Despite widespread use of narcotics [sic] drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction,” Jick wrote. Unfortunately, this quote was given far more merit than it deserved. Moreover, the conclusion had not been subjected to peer review.

In 1990, Scientific American called the Jick/Porter research “an extensive study.” About a decade later, Time proclaimed it “a landmark study.” Most significantly, Purdue Pharmaceuticals, maker of the popular narcotic OxyContin, began a promotion asserting less than one percent of patients treated with their time-released opiate medication OxyContin would become addicted. In the 1990s, pain was correlated with a greater probability of a patient having ongoing health issues. So the medical community elevated it to the position of the fifth vital sign along with heart rate, blood pressure, body temperature, and respiratory rate. The medical community, thinking that reducing pain would help long-term patient satisfaction, health and outcomes, started to prescribe more pain meds.

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The ’90s also saw the development of stronger and more effective opioid painkillers. As the decade drew to a close, the opioid epidemic was ignited. It took some time for most of the country to realize the metaphorical fuse had been lit, but the numbers back up this concern. According to the U.S. Department of Health and Human Services (HHS), between 2000 and 2017 opioid prescriptions increased 400 percent. Between 2000 and 2010, misuse involving noncompliance with prescription instructions or using medications prescribed for another person doubled. Now, the results are playing out in heartbreaking fashion nationwide, which are impossible to ignore. Overdose deaths—116 per day, according to federal statistics—are shaking Americans of all incomes, ages, and ethnicity. From the rural back roads of Appalachia (Kentucky, West Virginia) to the urban sprawl of New York and Los Angeles, the epidemic is cutting a path that threatens to leave no family unscathed.

The Blame Game

It’s become quite popular (if not convenient) to lay the blame for the epidemic squarely at the feet of the big pharmaceutical companies. For example, according to an article in the Los Angeles Times in May of this year, more than 350 cities, counties, and states had filed lawsuits against makers and distributors of opioid painkillers. The LA civil action accuses drugmakers and distributors of deceptive marketing aimed at boosting sales, claiming the companies borrowed from the “tobacco industry playbook.” One of the companies most frequently put under scrutiny has been Purdue Pharma, maker of OxyContin.

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In May The New York Times called Purdue “the company that planted the seeds of the opioid epidemic through its aggressive marketing of OxyContin.” The Times article uncovered a disturbing report on OxyContin compiled by the U.S. Department of Justice, which found that Purdue Pharma knew about and concealed significant incidents of abuse of OxyContin in the first years after the drug hit the market in 1996. The article further noted that Purdue Pharma admitted in open court in 2007 that it misrepresented the data regarding OxyContin’s potential for abuse.

Overdose Deaths Not Just Related to Opiate Prescriptions

Government reports have recently stated that today’s increase of fatal opioid-related overdoses is being driven by abuse of heroin and illicit fentanyl. A study prepared by the National Institute on Drug Abuse last September found that overdose deaths from heroin and other drugs laced with fentanyl increased 600 percent between 2002 and 2015. Street dealers have increasingly been cutting their drugs with fentanyl—a particularly dangerous and relatively inexpensive substance 50 to 100 times more powerful than morphine—to boost their profit margins. In most cases, the users don’t even realize they’re buying fentanyl-laced products.

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It is important to note that although many people believe Big Pharma is complicit in fueling the epidemic and should shoulder the loin’s share of the blame, Dr. Benzio sees it differently. “Pharmaceutical companies only make the meds,” Benzio says. “Only about 6 to 8 percent of people who take an opioid will misuse or overuse it in a destructive way. It is the doctors who over-prescribe and a society that is looking for a quick fix and can’t tolerate any discomfort [that’s to blame].”

The Road Ahead

The opiate epidemic may have grown somewhat quietly, but the nation’s attention is riveted to it now and policymakers aren’t sitting still. In 2016, Massachusetts became the first state to limit the duration for painkiller prescriptions at seven days. Since then, more than two dozen other states have also established limits. In my home state of Pennsylvania, Governor Tom Wolf initiated a statewide prescription drug monitoring system to help prevent prescription drug abuse. Of concern is the practice of “doctor shopping,” which involves a patient visiting multiple doctors and emergency departments in search of opioids. Unfortunately, this is something I did quite often while in active addiction. This practice often necessitates filling prescriptions at multiple pharmacies. The governor’s new policy includes the monitoring program, a standing order for naloxone (Narcan, used to reverse the effects of an opiate overdose), a patient non-opioid directive (which allows patients to opt out of opioid pain medicine in advance) a “warm hand-off” where ER attending physicians and other providers can set up a face-to-face introduction between a patient and a substance abuse specialist, and revised prescribing guidelines relative to opiates.

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At the federal level, President Donald Trump declared the opioid crisis a public health emergency in 2017, and formed a commission to fight it. Meanwhile, HHS now has a multi-pronged strategy to get the crisis under control, including getting better data through research and improving prevention, treatment, pain management, and recovery services. The federal crackdown is estimated to cost $13 billion to $18 billion over the next two years. Dr. Benzio believes this is “a good start,” but said providers must resist the urge to automatically jump to the quick fix of narcotics for those in pain. “There are many ways to combat pain through physical therapy and fitness, relaxation, better sleep and nutrition,” says Benzio. It seems likely that we will not get a significant handle on opioid abuse until the core issues that lead people to the drugs are addressed.

The Christian Perspective

W. David Hager, M.D., a member of the PRC, notes three principle root issues in addiction: rejection, abandonment and abuse. Hager has been a facilitator for the Christian program Celebrate Recovery. He said, “Unless we enable [people] to identify their root issue and deal with it first, the rates of relapse are high. When they are able to deal with their root issues by offering forgiveness, making amends, and seeking a personal relationship with Jesus Christ, we find that large numbers are able to enter and maintain sobriety.” That is why the Church has the unique ability to make a difference in combating the opioid crisis.

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“We have to convince faith-based communities to get their hands dirty, to get involved and realize that this is an issue,” Benzio says. He suggests inviting laypeople to develop a working knowledge of dopamine, the brain chemical that provides the pleasure-inducing sensation many who use drugs are seeking. “There is only one [higher] power that can sever synapses in the brain that have been stimulated by a substance to achieve [a certain] dopamine level,” he adds, “and that’s the power of the Holy Spirit.”

Exactly how Christians appropriate the Spirit’s power to take on the opioid crisis will vary from case to case. The point, Benzio and Hager say, is that this needs to become a top-of-mind concern for the Church. But are North American churches up to the mission of addressing opioid use among their members? Pastors are in a unique position to proclaim and demonstrate the Gospel to individuals struggling with addiction. Many are too ashamed to confess an addiction to pain medication. As the opioid crisis deepens, so must the response of the local church. If the Christian church has anything to offer those hurting from drug addiction, it is hope and community. I was only able to break the bondage of addiction over my life through the Power in the Name of Jesus.

Power in the Name of Jesus

Programs such as Narcotics Anonymous and Celebrate Recovery have been extremely effective in changing lives, but it’s not always enough. Addressing the root of addiction is one of the most effective long-term solutions, which for Christians is about the heart. The church must be willing and capable of seeing those struggling with addiction as not merely a program of the church’s community outreach; these individuals are children of a God who loves them no matter their current condition. I believe America’s recovery can find its roots in the local church.

What does love look like? It has the hands to help others. It has the feet to hasten to the poor and needy. It has eyes to see misery and want. It has the ears to hear the sighs and sorrows of men. That’s what love looks like. -St. Augustine

 

 

NIH Study Yields Important Insight Into Addiction and Pain

From the web blog of Dr. Lora Volkow, director of the National Institute of Drug Abuse dated May 6, 2018.

We are on the verge of a new era in medicine, one that truly treats the patient as an individual and as a participant in his or her own care. New data-gathering and analytic capabilities are enabling the kinds of massive, long-term studies needed to investigate genetic, environmental, and lifestyle factors that contribute to disease. Fine-grained insight into prevention and treatment is creating a truly precision, individualized form of medicine, the payoffs of which are already striking in such areas as cancer treatment.

Recently, the NIH Precision Medicine Initiative launched All of Us, a massive study set to gather data from a million Americans across all demographic, regional, and health/illness spectrums. It will use electronic health records to track the health and medical care received by participants for a decade or more, incorporating surveys, blood and urine samples, and even data from fitness trackers or other wearable devices. For the time being, recruitment is limited to those 18 or older, but future stages will include children as well. The data will be open-access for researchers—and of course, anonymous.

The All of Us study will benefit addiction science in many ways, such as yielding valuable data on the influence of substance use and substance use disorders on various medical conditions. Information on use of alcohol, tobacco, opioids, and perhaps other substances is liable to be captured in the electronic health records used for this study, and surveys will also capture lifestyle-related information including substance use and misuse. Gathering these records and survey data over time will provide important insight into how common forms of substance use impact treatment outcomes for a range of common diseases. It could yield valuable insights into genetic risk factors for substance use and substance use disorders as well as predictors of responsiveness to treatment using different medications. Links between substance use, substance use disorders, and other psychiatric problems such as depression and suicide can also be explored with such a large sample.

Factors affecting pain and its treatment are also directly relevant to addiction, especially in the context of the current opioid crisis. All of Us could provide valuable data on demographic variations in pain prescribing, telling us what groups (ethnic, age, and gender) are being prescribed opioids as opposed to other medications or non-pharmacological treatments. It will also tell researchers how these treatments affect patients’ lives. This data set will help answer questions about the role opioid treatments may play in the transition from acute to chronic pain, for instance, and what role opioid treatment plays in development of opioid use disorders or other substance use disorders. It will also help us understand what other factors, such as mental health or other co-morbidity, affects trajectories associated with pain.

Like the ABCD study currently underway to study adolescent brain development, the All of Us study is deliberately open-ended. It is understood that rapidly advancing technology will give us the ability not only to answer new questions but also ask questions that might not even occur to researchers currently. Consequently, All of Us is being designed to allow the ingenuity of the research community to explore how this dataset can be utilized and design new ways of making it address their specific research questions.

The Law of Powerlessness

pow·er·less·ness –ˈpourləsnəs/ noun: lack of ability, influence, or power.

The first step of a 12-step program is to admit that you are powerless over your addiction, and consequently, your life has become unmanageable. For many, this is one of the hardest things to do. While it is important to believe in your ability to overcome your addiction, you first must admit that you have an addiction and you need help in order for things to change. Until you do so, drugs, alcohol and other addictions will continue to exert their power over you and control every aspect of your life. The power of admitting powerlessness is that it is the first step to taking back your life.

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We struggle with the concept of powerlessness because it feels so much like helplessness. But God often works through our weakness to bring healing to our lives. It may seem like a contradiction, but there is great strength to be found in recognizing that, within ourselves, we do not have power over an aspect of our lives. The idea that powerlessness will result in strength is the most difficult law to understand and embrace. It is paramount, however, that recovery begin with an understanding of powerlessness. Of note is the fact that powerlessness is vividly portrayed throughout the Bible. In the Book of Judges, for example, we see a pattern in the lives of the Israelites that is similar to the pattern of our own lives.

Our thinking goes something like this. We get so caught up in our own plans and schemes that we stop caring about other people, and we refuse to acknowledge that there is a real God, who deserves respect and obedience. Blinded to the needs of others and the commands of God, we become trapped in our deficient, defective, and devastating ways of trying to find peace and comfort in the midst of all of the problems we have caused for ourselves. Refusing to give up, we try harder and harder to make things work the way we want them to. As we do, we hurt our families and communities and move further away from God.

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Finally, we hit bottom, and there is no way to go but up. Our willingness to change is still weak, and the thought of giving up our addiction is just about the last thing we want to do, but the truth starts to seep into our pores and eventually saturates enough of our being that we begin to see and feel our powerlessness—which has been there all along, throughout our egotistical rants and maniacal attempts to regain control of our lives. As we awaken to our own powerlessness, we begin, for the first time, to allow God to provide us with His strength and to show us His love. As we see even the faintest hint of His strength, we begin to understand how ridiculously powerless we are—and always have been—and we start to allow God to work with us.

As we continue to rely on God’s strength, we begin the step-by-step march toward recovery, transformation, restoration, and victory. As long as we awaken each day to the reality that we are powerless to change ourselves, God will provide His strength as needed, and everything will come together for us.

Disobedience-

As we so often do, the Israelites brought tremendous trouble on themselves by thinking they had everything figured out and under control. Instead of being obedient to the ways of God, they did all sorts of evil and unwise things and fell into the hands of a marauding people called the Midianites. The Midianites either ate or destroyed the Israelites’ crops until God’s people were starving. In fact, the Midianites were so cruel that the Israelites made hiding places for themselves in the mountains, caves, and strongholds.

Though the precise details may differ, the Israelites were just like us. We seek comfort in gluttonous amounts of food, alcohol, pornography, adultery, drugs, possessions, and many other compulsions. Rather than connecting us with God and others, these pursuits eventually send us to the hills and caves to hide our shame—that is, if we’re fortunate enough to still possess a conscience. We sometimes spend years of disconnection, fighting for our lives; until, one day, in a state of powerlessness we do what the Israelites did: We cry out to God for help.

Does any of this sound familiar? “Oh Lord, help me and I will never go back to my old ways.” “God, if you will allow me to live, I promise I will live for you.” “God, if you really are God, please show up in my life and get me out of this mess I’ve created for myself.” “Oh God, this time I mean it. Help me now and I will serve you forever.” Interestingly, God would rather hear us say, “Lord, I repent of my wanton lifestyle. I admit I am powerless over [insert addiction], and can do nothing without you. Whether you get me out of this mess or not, I choose to serve you.”

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God heard the Israelites and responded, just as He responds to us when we finally realize that we have no power. This is precisely where I failed. I seemed incapable of admitting that I was powerless. I simply did not want to see myself as weak or helpless. We read in Judges 6 that Gideon, who was sent by God to strike down the Midianites, is the weakest of the weak, from the weakest clan in Manasseh. When the angel of the Lord appeared to Gideon, he said, “The Lord is with you, mighty warrior” (Judges 6:12). Did you get that? Up to this point, Gideon had done nothing but be afraid and whiny, yet God called him a hero. God knew what Gideon was going to do, and He addressed him according to what He saw Gideon becoming in the future.

So how often have you gotten in trouble because you felt weak and alcohol, sex, cocaine, opiates, or other addictions made you feel strong—or maybe less weak? You probably thought you were not blessed but cursed by God. When our physical, mental, or emotional handicaps have seemed to disqualify us from making a difference, in the pain of that rejection we have sought comfort from things that could not cure us or even help us. But if we would have read, understood, and believed God’s Word, we would have known that we were perfectly situated for God to do great things through us. People would know that, because of our blatant weakness, it was the power of God and not our own power that produced the result.

Right now, if you are feeling as if there is no hope for your broken life, you’re wrong. You are missing God’s invitation. Maybe you’ve committed a heinous act, and your actions have shown that you are powerless over the urges that lead you to that darkest of places. God is calling upon you to admit your powerlessness and allow Him to give you the strength to confess what you’ve done, pay the legal penalty for the offense, and make restitution for the pain you have caused. Yes, you—a child molester, a wife beater, an arsonist, a drug dealer, a prostitute, an embezzler, or a murderer—are nonetheless a creation of an all-powerful God. When you are willing to admit to Him that you are powerless and are willing to make things right in His way, He will give you the strength to do it. Just as He did with Gideon.

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Back to Gideon. The weakest man from the weakest family in the weakest clan in Israel was now put in charge of the weakest imaginable fighting force and told to go into battle—but to do it God’s way. The battle wasn’t pretty, but with jars and ram’s horns and swords and shouts, 300 men, led by an unlikely hero, defeated 135,000 enemy troops. Here’s the point: Gideon was able to admit he was powerless. He knew that without the strength of God, he was still the same powerless, fearful, least-of-the-least man who had cowered in the bottom of a wine press. In the areas of our greatest weakness, God’s strength has allowed us to do the impossible.

Where are you when it comes to the law of powerlessness? Do you still feel as if you have some power left to try a little harder and do a little better and fix yourself? I wanted to be able to fix myself. I guess I thought mom, dad, my brothers and sister, my sons, and the girl in my life would determine I was finally “okay” if I had the personal power to deny my craving for drugs and alcohol. Just stop. I hope you are not holding such an opinion about yourself and your situation. You must come to the end of your rope and turn to God. He has not forgotten you. He has never left you. He has actually been waiting for you to decide to do what He will not force you to do. Remember, we’ve been given free will. He has been waiting for you to call upon Him, admit your powerlessness, and ask for His strength to empower your life.

The law of powerlessness says that if you truly understand and acknowledge that you are powerless, you are about to be provided with all the power you need. If you will simply do the next right thing, one day at a time, a time will come when you will feel as if you are soaring high on eagles’ wings. Don’t miss the remarkable recovery and restoration God has designed for you. If you feel too weak to move forward, admit your weakness to God. Remember what we’re told in 2 Corinthians 12:9: “My grace is enough; it’s all you need. My strength comes into its own in your weakness” (The Message).

If you are feeling weaker than you have ever felt, you are right where God does His very best work. If you will continue to allow Him to, He will do His best work in you, through you, and with you. Don’t give up or give in. Great changes are about to happen in your life and in the lives of those around you. I have been as good as dead in my sin and addiction, truly unable to help myself, pridefully convinced I could pull myself out of a tailspin that was sure to end in a complete crash-and-burn. I was embroiled in active addiction, in bondage to pornography, and committed to protecting my secrets at any cost. But God stayed with me. He continued to reach out through others. Conviction of the Holy Spirit laid bare my sinful conduct. I was completely powerless, but couldn’t bring myself to admit it.

If God can turn my weakness into strength, He can turn your weakness into strength as well. Admitting that we’re powerless is not a decision in the same way that surrendering would be. It is simply a realization of our limitations as human beings. If you’re finally ready to admit your own powerlessness, take a few minutes to memorize the truth in Philippians 4:13: “I can do all things through Him who strengthens me” (NASB). Then get on your knees and admit to God that without Him you cannot break the bondage of addiction. The dichotomy is that there is power in being able to accept your powerlessness.

God bless.

 

The Role of Science in Addiction

SPECIAL REPORT
From the New England Journal of Medicine
May 31, 2017
By Nora D. Volkow, M.D, and Francis S. Collins, M.D., Ph.D.

Opioid misuse and addiction is an ongoing and rapidly evolving public health crisis, requiring innovative scientific solutions. In response, and because no existing medication is ideal for every patient, the National Institutes of Health (NIH) is joining with private partners to launch an initiative in three scientific areas:

  1. developing better overdose-reversal and prevention interventions to reduce mortality, saving lives for future treatment and recovery;
  2. finding new, innovative medications and technologies to treat opioid addiction; and
  3. finding safe, effective non-addictive interventions to manage chronic pain.

Overdose-Reversal Interventions

Every day more than 90 Americans die from opioid overdoses. Death results from the opioid’s antagonistic effect on brainstem neurons that control breathing. In other words, the victim succumbs to respiratory failure. Naloxone can be used effectively to reduce the effect of opioid intoxication, thereby reversing the overdose, if it is administered in time. Although naloxone has saved tens of thousands of lives, overdoses frequently occur when no one else is around, and often no one arrives quickly enough to administer it.

Overdose fatalities have also been fueled by the increased availability of very powerful synthetic opioids such as fentanyl and carfentanil (50-100 times and 5,000-10,000 times more potent than heroin respectively). Misuse or accidental exposure to these drugs (e.g., when laced in heroin) is associated with very high overdose risk, and naloxone doses that can often reverse prescription-opioid or heroin overdoses may be ineffective. New and improved approaches are needed to prevent, detect and reverse overdoses.

Treatments for Opioid Addiction

The partnership will also focus on opioid addiction (the most serious form of opioid use disorder), which is a chronic, relapsing illness. Abundant research has shown that sustained treatment over years or even a lifetime is often necessary to achieve and maintain long-term recovery. Currently, there are only three medications approved for treatment: methadone, buprenorphine, and extended-release naltrexone. These medications, coupled with psychosocial support [such as rehab and 12-step programs] are the current standard of care for reducing illicit opioid use, relapse risk, and overdoses, while improving social function. There is a clear need to develop new treatment strategies for opioid use disorders. New pharmacologic approaches aim to modulate activity of the reward circuitry of the brain.

Non-Addictive Treatment for Chronic Pain

The third area of focus is chronic pain treatment: over-prescription of opioid medications reflects in part the limited number of alternative medications for chronic pain. Thus, we cannot hope to prevent opioid misuse and overdose without addressing the treatment needs of people with moderate-to-severe chronic pain. Though more cautious opioid prescribing is an important first step, there is a clear need for safer, more effective treatments.

Foremost is the plan to develop formulations of opioid pain medication with built-in abuse deterrent properties that are more difficult to manipulate for snorting or injecting, the routes of administration most frequently associated with misuse because of their more immediate rewarding effects. Such formulations, however, can still be misused orally and still lead to addiction. Thus, a more promising long-term avenue to addressing pain treatment will involve developing a powerful non-addictive analgesic. There are some fascinating x-ray crystallography studies going on that look promising.

Non-pharmacologic approaches being explored today, including brain-stimulation technologies such as high-frequency repetitive transcranial magnetic stimulation (rTMS, already FDA-approved for depression), have shown efficacy in multiple chronic pain conditions. At a more preliminary stage are viral-based gene therapies and transplantation of progenitor cells to treat pain. NIH researchers are investigating the use of gene therapy to deliver a potent anti-inflammatory protein directly to painful sites. Pre-clinical studies show powerful and long-lasting effects in reducing pain without side effects such as numbness, sedation, addiction, or tolerance.

Public-Private Partnerships

In April 2017, the NIH began discussions with pharmaceutical companies to accelerate progress on identifying and developing new treatments that can end the opioid crisis. Some advances may occur rapidly, such as improved formulations of existing medications, opioids with abuse-deterrent properties, longer-acting overdose-reversal drugs, and repurposing of treatments approved for other conditions. Others may take longer, such as opioid vaccines, and novel overdose-reversal medications. For all three areas, the goal is to cut in half the time typically required to develop new safe and effective therapeutics.

As noted throughout the history of medicine, science is one of the strongest allies in resolving public health crises. Ending the opioid epidemic will not be any different. In the past few decades, we have made remarkable strides in our understanding of the biologic mechanisms that underlie pain and addiction. But intensified and better-coordinated research is needed to accelerate the development of medications and technologies to prevent and treat these disorders. The scope of the tragedy of addiction and overdose deaths plaguing our country is daunting. The partnership between NIH and others will take an all hands on deck approach to developing and delivering the scientific tools that will help end the opiate epidemic in America and prevent it from reemerging in the future.

References

Volkow, N. and Collins, F. (May 31, 2017). “The Role of Science in Addressing the Opioid Crisis.” The New England Journal of Medicine. DOI: 10.1056/NEJMsr1706626

Volkow, L. (May 31, 2017). “All Scientific Hands On Deck to End the Opioid Crisis.” [Web blog comment]. Retrieved from : https://www.drugabuse.gov/about-nida/noras-blog/2017/05/all-scientific-hands-deck-to-end-opioid-crisis