Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yale University
Sponsor:
Collaborators:
St. Petersburg State Pavlov Medical University
Information provided by (Responsible Party):
Marek Cezary Chawarski, Yale University
ClinicalTrials.gov Identifier:
NCT01389167
First received: July 5, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
Drug: Vivitrol
Drug: Naltrexone (oral)
Behavioral: BDRC
Behavioral: Medical Management
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • reductions in sex- and drug-related HIV risk behaviors [ Time Frame: every month during 6 months of active study phase and during the 6 month follow-up ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: every month during 6 months of active study phase and during the 6 month follow-up ] [ Designated as safety issue: No ]
  • treatment retention (time to last clinical contact during outpatient treatment phase [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reductions in illicit use of other drugs [ Time Frame: every month during 6 months of active study phase and during the 6 month follow-up ] [ Designated as safety issue: No ]
  • improvements in vocational, family, social functioning, and quality of life indices [ Time Frame: every month during 6 months of active study phase and during the 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: September 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vivitrol + BDRC Drug: Vivitrol
An extended release naltrexone formulation for intramuscular injection
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.
Experimental: Vivitrol + Medical Management Drug: Vivitrol
An extended release naltrexone formulation for intramuscular injection
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.
Experimental: Naltrexone (oral)+BDRC 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.
Experimental: Naltrexone (oral) + Medical Management Drug: Naltrexone (oral)
Naltrexone 50 mg pills, daily
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.

Detailed Description:

With an estimated 1.6-4 million opiate users (majority with injection drug use (IDU)) and more than 940,000 HIV infected individuals (80% linked to IDU), the Russian Federation is facing the prospect of an explosive HIV epidemic. Currently in Russia, inpatient detoxification followed by oral naltrexone maintenance (NMT) is the only pharmacologic treatment for opiate dependence. Evidence-based counseling to reduce HIV transmission and relapse following detoxification is not widely available or routinely provided. Several considerations, including data from our preliminary studies, suggest that the efficacy of NMT may be improved by using extended-release naltrexone (XR/NTX) instead of oral naltrexone (O/NTX) and by combining NMT with behavioral drug and HIV risk reduction counseling (BDRC). BDRC may also improve medication adherence and promote behavioral change leading to reduced relapse risk, IDU, and other drug- and sex-related HIV risk behaviors. However, the efficacy and cost-effectiveness for reducing drug- and sex-related HIV risk behaviors and increasing duration of opioid abstinence of the various combinations of naltrexone formulation (O/NTX vs. XR/NTX) and counseling (MM only or combined with BDRC) have not been systematically evaluated. Consequently, we are proposing a 2x2 factorial randomized clinical trial evaluating the efficacy and cost-effectiveness of two medication formulations (O/NTX and XR/NTX) and two manual-guided counseling conditions (MM only or MM+BDRC) and the potential interactions between medications and counseling conditions. Following detoxification, opiate dependent subjects (N=320) will be randomly assigned to 6 months of treatment in one of four treatment groups: O/NTX+MM, XR/NTX+MM, O/NTX+MM+BDRC, or XR/NTX+MM+BDRC. Primary outcome measures include reductions in sex- and drug-related HIV risk behaviors, reductions in illicit opiate use, and treatment retention. Other outcome measures include reductions in frequency of opiate or other drug use, health status and healthcare utilization, criminal behavior and arrests, and improvements in vocational and family functioning and quality of life. All study participants will be assessed at baseline and monthly during the 6 month treatment phase and for 6 months following the active treatment phase. Data analyses will focus on the intention-to treat sample. The study results will allow evaluation of whether XR/NTX has superior efficacy or is more cost-effective than O/NTX, whether BDRC plus MM has superior efficacy or is more cost-effective than MM only, and whether particular combinations of medications and counseling have superior efficacy or are more cost-effective than other combinations.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389167

Contacts
Contact: Evgeny Krupitsky, Ph.D., M.D. +7-812-365-2217 kruenator@gmail.com

Locations
Russian Federation
Pavlov State Medical University Not yet recruiting
St Petersburg, Russian Federation
Contact: Evgeny Krupitsky         
Pavlov University Recruiting
St. Petersburg, Russian Federation
Contact: Evgeny Krupitsky, Ph.D., M.D.    +7-812-365-2217    kruenator@gmail.com   
Principal Investigator: Edwin Zvartau, M.D., Ph.D.         
Sponsors and Collaborators
Yale University
St. Petersburg State Pavlov Medical University
  More Information

No publications provided

Responsible Party: Marek Cezary Chawarski, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01389167     History of Changes
Other Study ID Numbers: 0907005456, R01DA027405
Study First Received: July 5, 2011
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014