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HIV Risk Reduction and Drug Abuse Treatment in Malaysia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383045
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : February 24, 2009
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: Buprenorphine/Subutex Drug: Naltrexone Procedure: Drug counseling Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: HIV Risk Reduction and Drug Abuse Treatment in Malaysia
Study Start Date : April 2003
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. Time to resumption of heroin use
  2. Time to relapse
  3. Maximum consecutive weeks of opiate abstinence
  4. Reduction of HIV risks

Secondary Outcome Measures :
  1. Addiction-related functional status
  2. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383045

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Substance Abuse Research Center
Muar, Johor, Malaysia
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
Study Director: Mahmud Mazlan, M.D. Hospital Muar, Malaysia

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00383045     History of Changes
Other Study ID Numbers: R01DA014718-04 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Keywords provided by Yale University:
HIV risk reduction behavior

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists