Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Vivitrol; Naltrexone (oral); BDRC; Medical Management
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): An extended release naltrexone formulation for intramuscular injection; Naltrexone 50 mg pills, daily; 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.; 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.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment