HIV Risk Reduction and Drug Abuse Treatment in Malaysia

NCT ID: NCT00383045

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2007-08-31

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.

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.

Conditions

Opiate Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Buprenorphine/Subutex

Intervention Type: DRUG

Naltrexone

Intervention Type: DRUG

Drug counseling

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Principal Investigators

Richard S. Schottenfeld, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Mahmud Mazlan, M.D.

Role: STUDY_DIRECTOR

Hospital Muar, Malaysia

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Substance Abuse Research Center

Muar town, Johor, Malaysia

Countries

United States; Malaysia

References

Mazlan M, Schottenfeld RS, Chawarski MC. New challenges and opportunities in managing substance abuse in Malaysia. Drug Alcohol Rev. 2006 Sep;25(5):473-8. doi: 10.1080/09595230600883354.

Reference Type: BACKGROUND

PMID: 16939945 (View on PubMed)

Chawarski MC, Mazlan M, Schottenfeld RS. Heroin dependence and HIV infection in Malaysia. Drug Alcohol Depend. 2006 Apr;82 Suppl 1:S39-42. doi: 10.1016/s0376-8716(06)80007-4.

Reference Type: BACKGROUND

PMID: 16769444 (View on PubMed)

Schottenfeld RS, Chawarski MC, Mazlan M. Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 28;371(9631):2192-200. doi: 10.1016/S0140-6736(08)60954-X.

Reference Type: DERIVED

PMID: 18586174 (View on PubMed)

Other Identifiers

R01DA014718-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0103012336

Identifier Type: -

Identifier Source: org_study_id