Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The long-term goals of this study are to foster development and dissemination of evidence-based behavioral and pharmacological treatments to reduce HIV transmission, injection drug use (IDU), and heroin use in Russia. This study will examine the effects of combining behavioral therapy with naltrexone pharmacotherapy for the treatment of opiate dependence and reduction of HIV risks in opiate dependent individuals. Specifically the study will determine whether extended-release injection naltrexone has greater efficacy and is more cost-effective than oral naltrexone maintenance, whether behavioral drug and HIV risk reduction counseling (BDRC) combined with brief, medical management (MM) has greater efficacy and is more cost-effective than MM only, and whether particular combinations of medication formulation and counseling (MM only or MM plus BDRC) have greater efficacy or are more cost-effective than other combinations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); St. Petersburg State Pavlov Medical University
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Detoxified volunteers seeking drug rehabilitation treatment will be eligible for the study

Exclusion Criteria:

• Current suicide or homicide risk

• Current psychotic disorder or major depression

• Inability to understand the consent form or assessments

• Pregnancy

• Acute hepatitis, liver failure, or liver enzymes greater than 3 times the upper limit of normal.