Official Title: “HIV Risk Reduction and Drug Abuse Treatment in Malaysia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

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(s) in this Clinical Trial

• Drug: Buprenorphine/Subutex
• Drug: Naltrexone
• Procedure: Drug counseling

Primary Measures

• Time to resumption of heroin use
• Time to relapse
• Maximum consecutive weeks of opiate abstinence
• Reduction of HIV risks

Secondary Measures

• Addiction-related functional status
• Adverse events

Inclusion Criteria:

• Opioid dependence

Exclusion Criteria:

• Dependence on alcohol, benzodiazepines or sedatives
• Suicide or homicide risk
• Psychotic disorder or major depression
• Inability to read or understand the protocol or assessment questions
• Life-threatening or unstable medical problems
• Greater than 3 times normal liver enzymes (AST, GGT)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Richard S. Schottenfeld, M.D. Principal Investigator Yale University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00383045

Study ID Number: R01-DA14718-04

ClinicalTrials.gov Identifier: NCT00383045

Health Authority: United States: Institutional Review Board