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HIV Risk Reduction and Drug Abuse Treatment in Malaysia

HIV Risk Reduction and Drug Abuse Treatment in Malaysia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00383045
Enrollment
180
Registered
2006-10-02
Start date
2003-04-30
Completion date
2007-08-31
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Dependence

Keywords

Buprenorphine, Naltrexone, HIV risk reduction behavior, Counseling

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.

Interventions

DRUGNaltrexone

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Addiction-related functional status
Adverse events

Countries

Malaysia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026