Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Post-Release Opioid Relapse
Study Overview
Brief Summary
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
Detailed Description
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults incarcerated in NYC jails with known release date
- •DSM-IV criteria for current opioid dependence
- •No current agonist (methadone, buprenorphine) treatment
- •Currently opioid free by history ('detoxed') and with a negative urine for all opioids
- •General good health as determined by complete medical interview and physical examination
- •Age 18-60 years.
Exclusion Criteria
- •History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
- •Pregnancy, lactation, or planning conception
- •Active medical illness that might make participation hazardous
- •Untreated psychiatric disorder
- •History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
- •Current chronic pain condition treated with opioids.
Arms & Interventions
Extended-release naltrexone (XR-NTX)
A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
Intervention: Extended-Release Naltrexone (Drug)
Motivational Enhancement Counseling Only
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Intervention: Motivational Enhancement Counseling (Behavioral)
Outcomes
Primary Outcomes
Post-Release Opioid Relapse
Time Frame: Four weeks post-release
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
Secondary Outcomes
- Participation in Community Drug Treatment Post-release(Four weeks post-release)
- Any Opioid Use Post-release(Four weeks post-release)
- Injection Drug Use Post-release(Four weeks post-release)
- Accidental Drug Overdose(Four weeks post-release)
- Adverse Events and Serious Adverse Events(Eight weeks post-release)
Investigators
Joshua D. Lee
Assistant Professor
NYU Langone Health