HIV Risk Reduction and Drug Abuse Treatment in Malaysia

Opiate Dependence Clinical Trial

Official title:

HIV Risk Reduction and Drug Abuse Treatment in Malaysia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383045
• Other study ID #: 0103012336
• Secondary ID: R01DA014718-04
• Status: Completed
• Phase: Phase 2
• Start date: April 2003
• Est. completion date: August 2007

Study information

• Verified date: February 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine/Subutex

• Naltrexone

Procedure:
• Drug counseling

Locations

Country	Name	City	State
Malaysia	Substance Abuse Research Center	Muar	Johor
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Malaysia, 

References & Publications (2)

Chawarski MC, Mazlan M, Schottenfeld RS. Heroin dependence and HIV infection in Malaysia. Drug Alcohol Depend. 2006 Apr;82 Suppl 1:S39-42. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to resumption of heroin use
Primary	Time to relapse
Primary	Maximum consecutive weeks of opiate abstinence
Primary	Reduction of HIV risks
Secondary	Addiction-related functional status
Secondary	Adverse events