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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opiate Dependence

Intervention / Treatment
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* Drug: Extended-Release Naltrexone
* Behavioral: Motivational Enhancement Counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended-release naltrexone (XR-NTX)<br>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. | Drug: Extended-Release Naltrexone<br>* 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).<br>* Other names: Vivitrol;|
| Placebo Comparator: Motivational Enhancement Counseling Only<br>The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. | Behavioral: Motivational Enhancement Counseling<br>* The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Release Opioid Relapse | 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. | Four weeks post-release | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation in Community Drug Treatment 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. | Four weeks post-release | 
| Any Opioid Use 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. | Four weeks post-release | 
| Injection Drug Use Post-release | This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail. | Four weeks post-release | 
| Accidental Drug Overdose | 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. | Four weeks post-release | 
| Adverse Events and Serious Adverse Events | AEs and SAEs per standard definitions will be measured by self-report. | Eight weeks post-release | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended-release naltrexone, Prisoners, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction