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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

July 5, 2011
February 6, 2014
September 2011
September 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01389167 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia
Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
  • 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.
  • Experimental: Vivitrol + BDRC
    Interventions:
    • Drug: Vivitrol
    • Behavioral: BDRC
  • Experimental: Vivitrol + Medical Management
    Interventions:
    • Drug: Vivitrol
    • Behavioral: Medical Management
  • Experimental: Naltrexone (oral)+BDRC
    Interventions:
    • Drug: Naltrexone (oral)
    • Behavioral: BDRC
  • Experimental: Naltrexone (oral) + Medical Management
    Interventions:
    • Drug: Naltrexone (oral)
    • Behavioral: Medical Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
May 2017
September 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Evgeny Krupitsky, Ph.D., M.D. +7-812-365-2217 kruenator@gmail.com
Russian Federation
 
NCT01389167
0907005456, R01DA027405
Yes
Marek Cezary Chawarski, Yale University
Yale University
  • St. Petersburg State Pavlov Medical University
  • National Institute on Drug Abuse (NIDA)
Not Provided
Yale University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP