How People with Substance Use Disorders (SUDs) Can Lend a Needed Hand in Addiction Research

FROM THE MONTHLY BLOG OF DR. LORA VOLKOW
April 22, 2019

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One of the major challenges in health science today is that not enough patients participate in clinical trials and similar studies. Without volunteers willing and able to participate in studies testing new treatments or therapeutic approaches for cancer or Alzheimer’s, for example, researchers cannot test their effectiveness. There are many reasons for the lack of participation in medical research: Patients often are not aware of studies, or they don’t see any direct benefit from participating. Many clinical trials for new cancer treatments, for example, have been delayed or even cancelled altogether because of the difficulty of recruiting participants.

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In research testing new medications or behavioral treatments for substance use disorders, the obstacles to recruiting study volunteers are even more daunting. Just finding participants can be a challenge, since they may not intersect with the healthcare system for their addiction, the same way someone with cancer or Alzheimer’s would. Only a fraction of people with substance use disorders receive care from physicians who may be in a position to know about or link them to research studies being planned. Most recruitment for clinical trials related to opioid addiction medications, for instance, is done via ads placed at large opioid treatment centers where patients on methadone receive their daily doses. 

People with substance use disorders already face stigma and the fear of further social or legal consequences of their addiction, and this deters potential volunteers from signing up to participate in research. Some distrust the medical profession altogether. Many people with addiction do not want or believe they need treatment at all. Additionally, because many people with addictions who might otherwise want to participate in a trial are unemployed, poor, or homeless (perhaps as a result of their substance use), they may lack the resources or access to transportation necessary to visit a hospital or research center regularly. Often as many as half or even more than half of participants recruited for a trial are not able to complete it.

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Scientists studying new treatment approaches for addiction must always be thinking about how they can make their research studies more practical and feasible in the real world. They must make study participation easy and appealing and the studies accessible—including access at odd hours or weekends for those whose jobs or school prevent participation during regular work hours. Also, people with addictions often use multiple substances, and this commonly excludes them from studies testing treatments for a single substance, due to strict criteria on who can be included in a trial. Yet the reality is that addiction is complex, and often involves not only use of multiple drugs but also co-occurring mental and physical illnesses. Designing more inclusive studies and clinical trials that can take this complexity into account will be necessary for scientific advancement in treating and preventing addiction.

An all-hands-on-deck approach is needed in order to confront America’s current drug crisis, and the needed hands must include families and individuals directly affected by substance use disorders. By increasing participation in research by those who most stand to benefit, we can find solutions to the complex addiction issues facing our nation today. It is also an opportunity for individuals suffering from addiction to participate in clinical research, just as people with other medical conditions do.

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For more information on the benefits of participating in a clinical trial—for addiction or any other disease—please feel free to visit https://www.nih.gov/health-information/nih-clinical-research-trials-you. Are you a provider? You can learn about trials to recommend to your patients here: https://www.nih.gov/health-information/nih-clinical-research-trials-you/finding-clinical-trial.

FIND HELP NEAR YOU

The following website can help you find substance abuse or other mental health services in your area: www.samhsa.gov/Treatment. If you are in an emergency situation, people at this toll-free, 24-hour hotline can help you get through this difficult time: 1-800-273-TALK. Or click on: www.suicidepreventionlifeline.org. In addition, you can find contact information in your phone book or online for Alcoholics Anonymous, Narcotics Anonymous, Celebrate Recovery, or other 12-step programs.

 

 

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.

New Funding Opportunities in Response to the Opioid Crisis

From the blog of Dr. Nora Volkow
Executive Director, National Institute on Drug Abuse
December 10, 2018

Today, NIDA is releasing several new funding opportunity announcements related to the NIH HEAL (Helping to End Addiction Long-term) Initiative. Researchers now can submit proposals for major projects funded through NIH HEAL in the areas of preventing opioid use disorder (OUD), improving OUD care in justice settings, determining the appropriate duration of treatment with medications to treat OUD, and better understanding how to manage mild or moderate OUD.

Prevention

Older adolescents and young adults (ages 16-30) are the group at highest risk for opioid initiation, misuse, OUD, and death from overdose, so targeting this age group for prevention interventions could have a sizeable impact on reducing the toll of opioid misuse and addiction. The research project called Preventing At-Risk Adolescents from Developing Opioid Use Disorder as they Transition into Adulthood will develop and test strategies to prevent initiation of opioid misuse and development of OUD in different healthcare settings (including primary care, emergency departments, urgent care, HIV/STI clinics, and school or college health clinics) as well as workplaces and justice settings. NIDA will fund a suite of integrated studies developing, testing, and validating screening and prevention tools in areas most affected by the opioid crisis or with indicators of an emerging crisis. For more information on funding opportunities related to this project, see the funding opportunity announcements for the Coordinating Center and research studies.

Criminal Justice System

Substantial research over the past several years has highlighted the consequences of untreated OUD in justice-involved populations—for instance, the high rates of overdose death among people recently released from prison—as well as showing the benefits of treating opioid-addicted prisoners using medication. It remains unknown what specific strategies are most effective at addressing opioid addiction in this population and reducing adverse outcomes. As part of the HEAL Initiative, NIDA will fund the creation of a network of researchers who can rapidly conduct studies aimed at exploring the effectiveness and adoption of medications, interventions, and technologies in justice settings.

The Justice Community Opioid Innovation Network will implement a survey of addiction treatment delivery services in local and state justice systems around the country and will develop new research methods to ensure that treatment interventions have the maximum impact.  For more information, please see the funding opportunity announcements for the Coordination and Translation Center, Methodology and Advanced Analytics Resource Center, and the research centers. 

Other Initiatives

In addition to the above referenced projects, NIDA will be partnering with other NIH institutes and centers on several opioid-related research projects. HEAL funds will also be used to answer some important research questions to address the opioid crisis. For example, NIDA’s Clinical Trials Network (CTN) will be utilized to determine the optimal length of medication treatment for opioid addiction and to identify treatment strategies to manage patients who present to primary or integrated care settings with low-level opioid misuse or OUD. Finally, HEAL funds are being considered to support a longitudinal study to understand the consequences of pre- and postnatal opioid and other substance exposure on the developing brain and behavior.

A silver lining of the dark cloud of the opioid crisis is that it has galvanized communities, healthcare systems, and government agencies to take significant steps toward ending opioid misuse and addiction in a compassionate, science-based way. The funds granted by Congress as part of the NIH HEAL. Initiative will accelerate scientific solutions to the crisis and generate new knowledge that will prevent future drug crises, as well as inform many other areas of medicine and public health. Information related to these projects is available on the NIH site.

Find Help Near You

The following website can help you find substance abuse or other mental health services in your area: www.samhsa.gov/Treatment. If you are in an emergency situation, people at this toll-free, 24-hour hotline can help you get through this difficult time: 1-800-273-TALK. Or click on: www.suicidepreventionlifeline.org

Using Science to Address the Opioid Crisis in America

FROM THE BLOG OF NORA VOLKOW, MD
September 19, 2018

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The public health emergency regarding opioid misuse, addiction, and overdose affects millions of Americans and requires innovative scientific solutions. Today, during National Prescription Opioid and Heroin Awareness Week, we are sharing news of an important step towards these solutions through the HEALing Communities Study—an integrated approach to test an array of interventions for opioid misuse and addiction in communities hard hit by the opioid crisis.

Six months ago, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-Term (HEAL) Initiative, a bold multi-agency effort to catalyze scientific discoveries to stem the opioid crisis. HEAL will support research across NIH, using $500,000 of fiscal year 2018 funds, to improve prevention and treatment of opioid use disorder and enhance pain management.

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Through HEAL, NIH will harness the power of science to bring new hope for people, families, and communities affected by this devastating crisis. The current menu of evidence-based prevention, treatment, and recovery interventions has not been fully implemented nationwide. An unacceptably low fraction – about one fifth — of people with opioid use disorder receive any treatment at all. Of those who do enter treatment, only about a third receive any medications—which are universally acknowledged to be the standard of care—as part of their treatment. However, even when medications are used as a component of treatment, the duration is typically shorter than clinically indicated, contributing to unacceptably high relapse rates within the first 6 months. 

To take on this challenge, as part of the broader HEAL initiative, NIH has partnered with the Substance Abuse and Mental Health Services Administration (SAMHSA) to launch the HEALing Communities Study. This study will evaluate the impact of implementing an integrated set of evidence based practices for prevention and treatment of opioid use disorders in select communities with high rates of opioid overdose mortality, with a focus on significantly reducing opioid overdose fatalities by 40%. Targeted areas for intervention include decreasing the incidence of opioid use disorder, increasing the number of individuals receiving medications for opioid use disorder treatment, increasing treatment retention beyond 6 months, receiving recovery support services, and expanding the distribution of naloxone.

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Toward this goal, today NIDA issued funding opportunities for cooperative agreements for components of the HEALing Communities Study: a data coordinating center and up to three research sites to measure the impact of integrating evidence-based prevention, treatment, and recovery interventions for opioid misuse, opioid use disorder, opioid-related overdose events and fatalities across multiple settings, including primary care, behavioral health, and justice. We also encourage evidence-based interventions for prevention and treatment that involve community resources such as police departments, faith-based organizations, and schools, with a focus on rural communities and strong partnerships with state and local governments.

The evidence we generate though the HEALing Communities Study, the most ambitious implementation study in the addiction field to date, will help communities nationwide address the opioid crisis at the local level.  By testing interventions where they are needed the most, in close partnership with SAMHSA and other Federal partners, we will show how researchers, providers, and communities can come together and finally bring an end to this devastating public health crisis.

The following website can help you find substance abuse or other mental health services in your area: www.samhsa.gov/Treatment. If you are in an emergency situation, people at this toll-free, 24-hour hotline can help you get through this difficult time: 1-800-273-TALK. Or click on: www.suicidepreventionlifeline.org. We also have step by step guides on what to do to help yourself, a friend or a family member on our Treatment page.

Partnering With Dentists and Oral Surgeons to Fight Opiate Addiction

From the blog of Dr. Nora Volkow, Executive Director of NIDA, posted July 25, 2018

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Reducing the reliance of doctors on potentially addictive opioid pain relievers has been one of the pillars of federal efforts to reverse the opioid crisis. Because many dental procedures such as extractions and other types of oral surgery often produce severe acute pain, dentists are among the largest prescribers of opioids. Thankfully, the dental profession has made significant progress in reducing opioid prescriptions. Two decades ago, when the opioid crisis was just starting, dentists accounted for 15.5 percent of all immediate-release opioid prescriptions; by 2012, they only wrote 6.4 percent of such prescriptions. Still, those in the oral health professions can play a key role in further improving the treatment of acute pain and making it safer.

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In March of this year, the American Dental Association (ADA) released a new policy on opiods, supporting limits on dosage and duration of opioid prescriptions and mandatory continuing education on their use, as well as recommending that dentists make use of their regional prescription drug monitoring program (PDMP). This policy is an important step toward protecting patients and their families from the potential harms of opioids. Following a meeting between representatives of the National Institute on Drug Abuse (NIDA), the National Institute of Dental and Craniofacial Research (NIDCR), and the ADA, NIDCR director Martha Somerman and Dr. Volkow wrote an editorial in this month’s issue of the Journal of the American Dental Association about how a partnership between NIH and oral health practitioners can continue to alleviate the opioid overdose epidemic.

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Increased knowledge of opioid prescribing practices among dentists, as well as among emergency department physicians when managing acute dental pain, is an important research priority. While dentists have reduced their opioid prescriptions, recent studies suggest the same is not true of emergency department providers when patients have dental pain. A study of Medicaid recipients showed that physicians in the ER prescribed opioids for dental pain five times more often than dentists in their own practices, and nurse practitioners in the ER prescribed opioids three times as often. Understanding the ways opioids are prescribed and the decisions underlying opioid prescribing can inform new clinical guidelines and policies to reduce the risks of opioid misuse. 

Concluding Remarks

Dentists can play a role in minimizing opioid abuse through patient education, careful patient assessment and referral for substance abuse treatment when indicated, and using tools such as prescription monitoring programs. Research is needed to determine the optimal number of doses needed to treat dental-related pain. Besides reducing their prescribing of opioids, these practitioners can learn to screen for opioid misuse and opioid use disorders, ultimately referring patients to treatment when indicated. To this end, NIDCR plans to fund research studies of interventions in rural communities.

These practitioners cannot assume that their prescribing of opioids does not affect the opioid abuse problem in the United States. Dentists, along with other prescribers, take steps to identify problems and minimize prescription opioid abuse through greater prescriber and patient education; use of peer-reviewed recommendations for analgesia; and, when indicated, the tailoring of the appropriate and legitimate prescribing of opioids to adequately treat pain.

Ambitious Research Plan to Help Solve the Opioid Crisis

From the blog of Dr. Lora Volkow, National Institute on Drug Abuse Posted June 12, 2018

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In spring 2018 Congress added an additional $500 million to the NIH budget to invest in the search for solutions to the opioid crisis. The Helping to End Addiction Long-term (HEAL) initiative is being kicked off June 12th with the announcement of several bold projects across NIH focusing on two main areas: improving opioid addiction treatments and enhancing pain management to prevent addiction and overdose. The funding NIDA is receiving will go toward the goal of addressing addiction in new ways, and creating better delivery systems for addictions counseling for those in need.

NIH will be developing new addiction treatments and overdose-reversal tools. Three medications are currently FDA-approved to treat opioid addiction. Lofexidine—a drug initially developed to treat high blood pressure—has just been approved to treat physical symptoms of opioid withdrawal. Narcan (naloxone) is available in injectable and intranasal formulations to reverse overdose. Regardless, more options are needed. One area of need involves new formulations of existing drugs, such as longer-acting formulations of opioid agonists and longer-acting naloxone formulations more suitable for reversing fentanyl overdoses. Compounds are also needed that target different receptor systems or immunotherapies for treating symptoms of withdrawal and craving in addition to the progression of opioid use disorders.

Much research already points to the benefits of increasing the availability of treatment options for Opioid Use Disorder (“OUD”), especially among populations currently embroiled in the justice system. Justice Community Opioid Innovation Network is working to create a network of researchers who can rapidly conduct studies aimed at improving access to high-quality, evidence-based addiction treatment in justice settings. It will involve implementing a national survey of addiction treatment delivery services in local and state justice systems; studying the effectiveness and adoption of medications, interventions, and technologies in those settings; and finding ways to use existing data sources as well as developing new research methods to ensure that interventions have the maximum impact.

The National Drug Abuse Treatment Clinical Trials Network (“CTN”) facilitates collaboration between NIDA, research scientists at universities, and a myriad of treatment providers in the community, with the aim of developing, testing, and implementing addiction treatments. As part of the HEAL initiative, the CTN Opioid Research Enhancement Project will greatly expand the CTN’s capacity to conduct trials by adding new sites and new investigators. The funds will also enable the expansion of existing studies and facilitate developing and implementing new studies to improve identification of opioid misuse and OUD. Further, it will enhance engagement and retention of patients in treatment in a variety of general medical settings, including primary care, emergency departments, ob/gyn, and pediatrics.

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A great tragedy of the opioid crisis is that there are a number of effective tools not being deployed effectively in communities in need. Only a fraction of people with OUD receive any treatment, and of those less than half receive medications that are universally acknowledged to be the standard of care. Moreover, patients often receive medications for too short a duration. As part of its HEAL efforts, NIDA will launch a multi-site implementation research study called the HEALing Communities Study in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA). The HEALing Communities Study will support research in up to three communities highly affected by the opioid crisis, which should help evaluate how the implementation of an integrated set of evidence-based interventions within healthcare, behavioral health, justice systems, and community organizations can work to decrease opioid overdoses and prevent and treat OUD. Lessons learned from this study will yield best practices that can then be applied to other communities across the nation.

The HEAL Initiative is a tremendous opportunity to focus taxpayer dollars effectively where they are needed the most: in applying science to find solutions to the worst drug crisis our country has ever seen.

Find Help Near You

The following website can help you find substance abuse or other mental health services in your area: www.samhsa.gov/Treatment. If you are in an emergency situation, people at this toll-free, 24-hour hotline can help you get through this difficult time: 1-800-273-TALK. Or click on: www.suicidepreventionlifeline.org. We also have step by step guides on what to do to help yourself, a friend or a family member on our Treatment page.

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.