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.