Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

PHASE3CompletedINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

September 30, 2016

Study Completion Date

May 31, 2017

Conditions
Opiate Dependence
Interventions
DRUG

Vivitrol

An extended release naltrexone formulation for intramuscular injection

DRUG

Naltrexone (oral)

Naltrexone 50 mg pills, daily

BEHAVIORAL

BDRC

Manual-guided BDRC is a highly structured, educational, prescriptive, and individualized treatment that focuses on the patient's current problem areas that are immediately related to marinating abstinence in order to achieve sustained recovery from drugs. The primary goals of BDRC include education about the disease of opiate dependence and effective treatment approaches, skills and strategies to maintain drug abstinence following detoxification, reduction/cessation of drug and sexual behaviors associated with HIV transmission, and increased engagement in non-drug-related social interactions and pleasurable activities.

BEHAVIORAL

Medical Management

Patient assigned to MM will receive manual-guided medically oriented counseling approximating the current standard of care provided in with NTM the Russian Federation, consisting of an initial introductory session (introduction to NMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month.

Trial Locations (1)

Unknown

Pavlov University, Saint Petersburg

All Listed Sponsors
collaborator

St. Petersburg State Pavlov Medical University

OTHER

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Yale University

OTHER

NCT01389167 - Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia | Biotech Hunter | Biotech Hunter