Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

NCT01389167 | Completed Phase 3 DMC

• 2 other identifiers: 0907005456R01DA027405
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opiate Dependence

Outcome Measures

Primary Outcomes (3)

• reductions in sex- and drug-related HIV risk behaviors

  every month during 6 months of active study phase and during the 6 month follow-up

• reductions in illicit opiate use (maximum consecutive days of abstinence following detoxification and number of days of heroin or illicit opiate use in the past 30 days)

  every month during 6 months of active study phase and during the 6 month follow-up

• treatment retention (time to last clinical contact during outpatient treatment phase

  6 months

Secondary Outcomes (2)

• reductions in illicit use of other drugs

  every month during 6 months of active study phase and during the 6 month follow-up

• improvements in vocational, family, social functioning, and quality of life indices

  every month during 6 months of active study phase and during the 6 month follow-up

Study Arms (4)

Vivitrol + BDRC

EXPERIMENTAL

Drug: Vivitrol; Behavioral: BDRC

Vivitrol + Medical Management

EXPERIMENTAL

Drug: Vivitrol; Behavioral: Medical Management

Naltrexone (oral)+BDRC

EXPERIMENTAL

Drug: Naltrexone (oral); Behavioral: BDRC

Naltrexone (oral) + Medical Management

EXPERIMENTAL

Drug: Naltrexone (oral); Behavioral: Medical Management

Interventions

Vivitrol DRUG

An extended release naltrexone formulation for intramuscular injection

Vivitrol + BDRC; Vivitrol + Medical Management

Naltrexone (oral) DRUG

Naltrexone 50 mg pills, daily

Naltrexone (oral) + Medical Management; Naltrexone (oral)+BDRC

BDRC BEHAVIORAL

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.

Naltrexone (oral)+BDRC; Vivitrol + BDRC

Medical Management BEHAVIORAL

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.

Naltrexone (oral) + Medical Management; Vivitrol + Medical Management

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• St. Petersburg State Pavlov Medical University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Pavlov University

Saint Petersburg, Russia

Location

Related Publications (1)

• Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

  PMID: 40342086 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol; Naltrexone; Practice Management, Medical

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Locations

RU (1)