NCT Number: NCT00383045
HIV Risk Reduction and Drug Abuse Treatment in Malaysia
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 2
Primary location
Substance Abuse Research Center, Muar town, Johor, Malaysia
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Naltrexone
DrugDrug counseling
ProcedurePrimary outcomes
-
Time to resumption of heroin use
-
Time to relapse
-
Maximum consecutive weeks of opiate abstinence
-
Reduction of HIV risks
Secondary outcomes
-
Addiction-related functional status
-
Adverse events
Sponsors and collaborators
Lead sponsor
Yale University
Other
Collaborators
- National Institute on Drug Abuse (NIDA)
Registry information
Important dates
- Study start
- 2003
- Study completion
- 2007
- First posted
- Oct 2, 2006
- Registry last updated
- Mar 31, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Impact of Lofexidine on Stress, Craving and Opioid Use
NCT03718065
Chemically-Induced Disorders, Mental Disorders
Charleston, South Carolina, United States
View Trial DetailsImaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
NCT03527485
Chemically-Induced Disorders, Cocaine Dependence
New Haven, Connecticut, United States
View Trial DetailsRemote Observed Dosing of Suboxone to Improve Clinical Practice
NCT03769025
Chemically-Induced Disorders, Mental Disorders
Philadelphia, Pennsylvania, United States
View Trial DetailsProject Relief: Developing Brain Stimulation as a Treatment for Chronic Pain
NCT04156802
Back Pain, Chemically-Induced Disorders
Winston-Salem, North Carolina, United States
View Trial Details