Phase 3 N=34 Randomized Treatment

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

Opiate Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01180647 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Post-Release Opioid Relapse — 6; 15 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Extended-Release Naltrexone (Drug); Motivational Enhancement Counseling (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-Release Opioid Relapse	6; 15	—
SECONDARY Participation in Community Drug Treatment Post-release	19; 12	—
SECONDARY Any Opioid Use Post-release	17; 82	—
SECONDARY Injection Drug Use Post-release	25; 6	—
SECONDARY Accidental Drug Overdose	0; 0	—
SECONDARY Adverse Events and Serious Adverse Events	5; 1	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01180647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.