Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
Opiate DependenceHuman Immunodeficiency Virus
Interventions
DRUG

injectable naltrexone

Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.

DRUG

placebo comparator

this placebo has no specific pharmacological activity

Trial Locations (1)

119002

Federal Medical Research Center for Psychiatry and Narcology (FMRC), Moscow

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

University of Pennsylvania

OTHER

NCT01882361 - Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone | Biotech Hunter | Biotech Hunter