Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

Phase 3

Completed

Interventions: Drug: Extended-Release Naltrexone
Behavioral: Motivational Enhancement Counseling

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Extended-release naltrexone (XR-NTX)	Extended-Release Naltrexone	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.
Motivational Enhancement Counseling Only	Motivational Enhancement Counseling	The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Primary Outcome Measures

Name	Time	Method
Post-Release Opioid Relapse	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 Outcome Measures

Name	Time	Method
Participation in Community Drug Treatment Post-release	Four weeks post-release	This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.
Any Opioid Use Post-release	Four weeks post-release	Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.
Injection Drug Use Post-release	Four weeks post-release	This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.
Accidental Drug Overdose	Four weeks post-release	Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.
Adverse Events and Serious Adverse Events	Eight weeks post-release	AEs and SAEs per standard definitions will be measured by self-report.

Locations (2): New York University School of Medicine
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New York, New York, United States
New York City Department of Correction
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New York, New York, United States