HIV Risk Reduction and Drug Abuse Treatment in Malaysia
Condition: Opiate Dependence
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV)
      alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine
      maintenance for the treatment of heroin addicts in Malaysia.
    

Detailed description: 
      Combining drug abuse and HIV risk reduction counseling with opioid agonist maintenance
      treatment (OMT) or antagonist maintenance treatment with naltrexone (NMT) is effective for
      reducing illicit drug use and preventing HIV transmission associated with heroin dependence,
      but support for NMT and OMT remains tenuous in many Western Pacific countries (e.g.,
      Malaysia, Indonesia and Singapore) where heroin addiction and HIV infection are epidemic and
      closely linked due to injection drug use (IDU) and high-risk sexual behaviors among addicts.
      Promising results of NMT in Malaysia have created interest in evaluating OMT using
      buprenorphine (BMT) and comparing the efficacy of counseling alone and counseling combined
      with BMT or NMT. This 24-week, randomized double blind clinical trial compares the efficacy
      for preventing heroin use and relapse and reducing HIV risk behaviors of manual-guided, HIV
      risk reduction and drug counseling (DC-HIV) alone or when combined with buprenorphine
      maintenance treatment (BMT) or naltrexone maintenance treatment (NMT) for recently detoxified
      and currently abstinent heroin dependent patients (N=180) in Malaysia (Specific Aim 1). The
      study will allow evaluation of 3 hypotheses: DC-HIV plus naltrexone is superior to DC-HIV
      alone; DC-HIV plus buprenorphine is superior to DC-HIV alone; and DC-HIV plus naltrexone is
      superior to DC-HIV plus buprenorphine. Primary outcome measures, assessed by 3x/wk urine
      toxicology testing and self-report, include resumption of heroin use, 1 or 3 weeks continuous
      relapse and reductions in HIV risk behaviors. The project will also evaluate the
      characteristics of treatment-seeking heroin addicts in Malaysia (including specific risk
      behaviors and patterns of HIV risk behaviors; prevalence of psychiatric and other medical
      comorbidity; and patterns of social, family, vocational, and criminal activity and service
      needs-Specific Aim 2). This data will be used to revise the DC-HIV manual to address the
      specific circumstances and risk behaviors of Malaysian heroin addicts. Finally, the project
      provides clinical training for health professionals and training and mentoring in drug abuse
      treatment and HIV prevention research to clinical researchers who will continue development,
      implementation, evaluation and dissemination of HIV prevention and drug abuse treatment
      approaches in Malaysia after the project ends (Specific Aim 3). The results of the study will
      inform government policy and support for HIV prevention and drug abuse treatment efforts in
      Malaysia and possibly also in other Western Pacific countries.
    

Intervention name(s): Buprenorphine/Subutex; Naltrexone; Drug counseling
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Naltrexone; Buprenorphine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Buprenorphine; Naltrexone; HIV risk reduction behavior; Counseling