Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China |
- Reductions of illicit opiate use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Reductions in HIV risk behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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
|
|
Active Comparator: B
Methadone maintenance treatment with standard drug counseling
|
Behavioral: Drug counseling
individual drug counseling
|
Detailed Description:
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:
- Conduct a preliminary evaluation of the feasibility, acceptability, and preliminary efficacy for increasing treatment retention and reducing drug use and HIV risk behaviors of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) when combined with Standard Methadone, in comparison to Standard Methadone, among opiate dependent treatment seeking volunteers admitted to the Wuhan Methadone Clinic.
- Develop estimates of the costs and cost-effectiveness of Standard Methadone and BDRC.
- Train and provide ongoing clinical supervision to a core group of 10 drug counseling staff and provide additional mentoring in drug abuse and HIV risk reduction research to investigators in China.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- opioid dependence
Exclusion Criteria:
- current dependence on alcohol, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or untreated major depression
- life-threatening or unstable medical problems
Contacts and Locations| United States, Connecticut | |
| Yale University School of Medicine - CMHC | |
| New Haven, Connecticut, United States, 06520 | |
| China, Hubei | |
| Wuhan Center for Disease Control and Prevention | |
| Wuhan, Hubei, China | |
| Principal Investigator: | Richard S Schottenfeld, MD | Yale University |
More Information
No publications provided
| Responsible Party: | Richard S. Schottenfeld, M.D., Yale University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00757744 History of Changes |
| Other Study ID Numbers: | R01DA014718-05A1S1, NIDA grant R01DA014718-05A1S1 |
| Study First Received: | September 22, 2008 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board China: Ethics Committee |
Keywords provided by Yale University:
|
drug counseling HIV risks methadone maintenance HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Opioid-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Substance-Related Disorders Mental Disorders |
Methadone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013