Prevention of Progression to Moderate or Severe Opioid Use Disorder
The Research Need
According to the Substance Abuse and Mental Health Service Administration’s 2018 National Survey on Drug Use and Health, an estimated 10.3 million people in the U.S. misused opioids in the past year. Of these individuals, only 2 million met the criteria for opioid use disorder (OUD).
Very little is known about the efficacy of interventions for people who do not meet the criteria for moderate or severe OUD. The prevalence of subthreshold OUD in primary care settings is 5-10 percent, and rates are higher (21-29 percent) among those receiving prescribed opioids. Those with subthreshold OUD are at high risk of developing moderate or severe OUD and/or dying from an overdose, and more empirical evidence is needed about pragmatic prevention interventions that integrated general medical settings can adopt.
About the Program
To study the efficacy of prevention interventions to arrest the progression from risky opioid use to more severe OUD, researchers will test the efficacy of a Subthreshold Opioid Use Disorder Prevention (STOP) intervention in primary care settings. Risky opioid use is defined as (1) having taken prescribed opioids for nonmedical use or having used illicit opioids and (2) meeting no more than three of five diagnostic criteria for OUD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
STOP adopts an early intervention approach based on a collaborative care model and consists of:
- A practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring, and guiding patients who have risky opioid use.
- Brief advice delivered to patients by their PCP.
- Phone counseling by behavioral health providers to motivate patients and support behavior change.
To date, through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, NIH has awarded approximately $12.6 million in funding to four institutions to conduct the STOP clinical trial.
This research will be carried out through the National Drug Abuse Treatment Clinical Trials Network (CTN), which brings medical and specialty treatment providers, researchers, patients, and the National Institute on Drug Abuse together.
The CTN supports rigorous, multisite clinical trials to determine the effectiveness of treatment strategies in a broad range of treatment settings and diverse patient populations and to ensure the timely transfer of research results to clinicians, providers, and their patients.
The expansion of the CTN, supported by the NIH HEAL Initiative, enhances the network’s scientific and clinical research capabilities and allows increased coverage in geographic regions most affected by the opioid overdose epidemic.
Researchers will determine whether STOP reduces risky opioid use. They will also examine the impact of STOP on progression to moderate or severe OUD, overdose risk behavior, and overdose events in adults with risky use of illicit or prescription opioids.
- Emmes Corporation – Maryland
- McLean Hospital – Massachusetts
- New York University School of Medicine – New York
- University of California, San Francisco – California