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

NYU Langone Health

Status and phase: Completed; Phase 3

Conditions: Opiate Dependence

Treatments: Drug: Extended-Release Naltrexone; Behavioral: Motivational Enhancement Counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01180647

NYU IRB Number: 09-0372

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups, including a placebo group

Extended-release naltrexone (XR-NTX)

Active Comparator group

Description:

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.

Treatment:

Drug: Extended-Release Naltrexone

Motivational Enhancement Counseling Only

Placebo Comparator group

Description:

The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Treatment:

Behavioral: Motivational Enhancement Counseling