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
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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:

  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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757744

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
Sponsors and Collaborators
Yale University
Investigators
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
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
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 16, 2014