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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00757744 |
Purpose
A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with methadone maintenance treatment in Wuhan, China
| Condition | Intervention | Phase |
|---|---|---|
|
Opiate Dependence HIV Infections |
Behavioral: Behavioral Drug and HIV Risk Reduction Counseling (BDRC) Behavioral: Drug counseling |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Factorial Assignment, Efficacy Study |
| Official Title: | Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Methadone maintenance treatment with Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
|
Behavioral: Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
once weekly individual counseling
|
|
B: Active Comparator
Methadone maintenance treatment with standard drug counseling
|
Behavioral: Drug counseling
individual drug counseling
|
This project is a supplement to a parent grant, Drug Counseling and Abstinence-Contingent Take-Home Buprenorphine in Malaysia. The specific aims of the parent grant include evaluating whether the relatively minimal counseling and other services provided with standard buprenorphine maintenance treatment (Standard BUP) is sufficient or whether one or a combination of two enhanced behavioral treatments--behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)—improve its efficacy (Specific Aim 1) and are cost-effective, with regard to the direct economic costs of providing the treatments (Specific Aim 2) and also to provide training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers and clinical training for health professionals in Malaysia (Specific Aim 4). BDRC utilizes short-term behavioral contracts to promote abstinence and reduce drug- and sex-related HIV risk behaviors and can be provided by nurses and medical assistants available in medical settings in developing countries.
The specific aims of the proposed study are consistent with the specific aims of the parent grant and include evaluating in a pilot, randomized clinical trial in a methadone treatment program in Wuhan, China, the feasibility and potential efficacy for reducing illicit drug use and HIV risk behaviors of BDRC when combined with standard methadone treatment services (Standard Methadone) compared to Standard Methadone only (Specific Aim 1 of the proposed study). Additional Specific Aims of the proposed study include developing estimates of the treatment costs and cost-effectiveness of Standard Methadone and BDRC (Specific Aim 2 of the proposes study), and providing training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers an clinical training for health professionals in China (Specific Aim 3 of the proposed study).
Specific aims of the China project:
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Wang Zhou, MD | 86-27-5951-2796 | rising-up@hotmail.com |
| United States, Connecticut | |
| Yale University School of Medicine - CMHC | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Marek C. Chawarski, PhD 203-974-7602 marek.chawarski@yale.edu | |
| Contact: Caroly Haller 203-974-7374 carolyn.haller@yale.edu | |
| Principal Investigator: Richard S. Schottenfeld, MD | |
| Sub-Investigator: Marek C. Chawarski, PhD | |
| China, Hubei | |
| Wuhan Center for Disease Control and Prevention | Recruiting |
| Wuhan, Hubei, China | |
| Contact: Wang Zhou, MD 86-27-5951-2796 rising-up@hotmail.com | |
| Principal Investigator: | Richard S Schottenfeld, MD | Yale University |
More Information
| Responsible Party: | Yale University School of Medicine ( Richard S. Schottenfeld, M.D. ) |
| Study ID Numbers: | R01DA014718-05A1S1, NIDA grant R01DA014718-05A1S1 |
| Study First Received: | September 22, 2008 |
| Last Updated: | June 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00757744 History of Changes |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board; China: Ethics Committee |
|
drug counseling HIV risks methadone maintenance HIV Seronegativity |
|
Respiratory System Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Physiological Effects of Drugs Disorders of Environmental Origin Opioid-Related Disorders Infection Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Analgesics Retroviridae Infections Analgesics, Opioid RNA Virus Infections |
Immune System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Depressants Narcotics Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Methadone HIV Infections Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents |