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Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00757744
First received: September 22, 2008
Last updated: May 16, 2011
Last verified: May 2011

September 22, 2008
May 16, 2011
September 2007
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00757744 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China
Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China

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

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:

  1. 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.
  2. Develop estimates of the costs and cost-effectiveness of Standard Methadone and BDRC.
  3. 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opiate Dependence
  • HIV Infections
  • Behavioral: Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
    once weekly individual counseling
  • Behavioral: Drug counseling
    individual drug counseling
  • Experimental: A
    Methadone maintenance treatment with Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
    Intervention: Behavioral: Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
  • Active Comparator: B
    Methadone maintenance treatment with standard drug counseling
    Intervention: Behavioral: Drug counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   China
 
NCT00757744
R01DA014718-05A1S1, NIDA grant R01DA014718-05A1S1
No
Richard S. Schottenfeld, M.D., Yale University School of Medicine
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Richard S Schottenfeld, MD Yale University
Yale University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP