HIV Risk Reduction and Drug Abuse Treatment in Malaysia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00383045
First received: September 28, 2006
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Opiate Dependence
Drug: Buprenorphine/Subutex
Drug: Naltrexone
Procedure: Drug counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: HIV Risk Reduction and Drug Abuse Treatment in Malaysia

Resource links provided by NLM:


Further study details as provided by Yale University:

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

Secondary Outcome Measures:
  • Addiction-related functional status
  • Adverse events

Estimated Enrollment: 180
Study Start Date: April 2003
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383045

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Malaysia
Substance Abuse Research Center
Muar, Johor, Malaysia
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Richard S. Schottenfeld, M.D. Yale University
Study Director: Mahmud Mazlan, M.D. Hospital Muar, Malaysia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00383045     History of Changes
Other Study ID Numbers: R01-DA14718-04
Study First Received: September 28, 2006
Last Updated: February 23, 2009
Health Authority: United States: Institutional Review Board
Malaysia: Ministry of Health

Keywords provided by Yale University:
Buprenorphine
Naltrexone
HIV risk reduction behavior
Counseling

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Mental Disorders
Buprenorphine
Naltrexone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014