Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00539123
First received: October 2, 2007
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

A randomized clinical trial evaluating whether Behavioral Drug and HIV Risk Reduction Counseling (BDRC), abstinence-contingent take-home buprenorphine (ACB), or the combination of the two improve efficacy and cost-effectiveness of standard buprenorphine treatment for opiate-dependent individuals in Malaysia.


Condition Intervention Phase
Opiate Dependence
Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
Behavioral: abstinence-contingent take-home buprenorphine (ACB)
Behavioral: Physician Management (PM)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • reductions in heroin use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • reductions in drug- and sex-related HIV risk [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • retention [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • reductions in other illicit drug use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • changes in functional status [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Physician Management (PM): medically focused advice and brief counseling
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
Experimental: 2
Physician Management (PM) plus Abstinence Contingent Buprenorphine (ACB) dispensing
Behavioral: abstinence-contingent take-home buprenorphine (ACB)
Patients achieving heroin abstinence receive take-home doses of buprenorphine
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
Experimental: 3
PM plus Behavioral Drug and HIV Risk Reduction Counseling (BDRC)
Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
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 Malaysia.
Behavioral: Physician Management (PM)
medically focused advice and brief counseling
Experimental: 4
PM plus BDRC plus ACB
Behavioral: behavioral drug and HIV risk reduction counseling (BDRC)
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 Malaysia.
Behavioral: abstinence-contingent take-home buprenorphine (ACB)
Patients achieving heroin abstinence receive take-home doses of buprenorphine
Behavioral: Physician Management (PM)
medically focused advice and brief counseling

Detailed Description:

Heroin and injection drug use (IDU) are highly prevalent and driving the HIV epidemic in Malaysia and other countries in the region. In our original RCT, buprenorphine (BUP) was superior to naltrexone and placebo in treatment retention, weeks of consecutive abstinence and time to heroin use. However, there is room for improvement, since only 50% of subjects assigned to BUP remained in treatment for 6 months; only 28% avoided relapse to heroin; and BUP reduced drug- but not sex-related HIV risk behaviors. In actual clinical practice in Malaysia and the U.S., Standard BUP is provided with relatively minimal psychosocial services (brief physician management (PM) and weekly or less frequent medication pick-up) and may be even less effective. Hence, we propose a follow up study to evaluate whether 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 and are cost-effective, with regard to the direct economic costs of providing the treatments. 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 Malaysia. ACB, a low cost and feasible alternative to non-contingent take-home buprenorphine, retains many of its advantages--abstinent patients manage their medication supplies outside of the clinic--but ACB also provides positive incentives for abstinence and directly observed buprenorphine for those with continuing heroin use. In the proposed 2X2 study, heroin dependent patients (N=240) will be inducted onto buprenorphine (weeks 1-2) and then randomized to Standard BUP, Standard BUP with ACB, Standard BUP with BDRC, or Standard BUP with both (weeks 3-26). Primary outcome measures include reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests, and maximum consecutive weeks abstinent) and reductions in drug- and sex-related HIV risk behaviors. Secondary outcomes include retention; reductions in other drug use, hospitalizations, criminal behavior and arrests; and improvements in vocational and family functioning. Data analyses will focus on the intention-to treat sample. The study results will inform practice guidelines and policies regarding buprenorphine treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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 major depression inability to understand protocol or assessment questions life threatening or unstable medical problems more than 3x normal liver enzymes
  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: NCT00539123

Contacts
Contact: Mahmud Mazlan, MD 60-6-953-2291 melaun@yahoo.com

Locations
United States, Connecticut
Yale University School of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06519
Malaysia
Substance Abuse Research Center Recruiting
Muar, Johor, Malaysia, 84000
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Richard S. Schottenfeld, MD Yale University
Study Director: Mahmud Mazlan, MD Substance Abuse Research Center, Muar
  More Information

No publications provided

Responsible Party: Richard S. Schottenfeld, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00539123     History of Changes
Other Study ID Numbers: 2R01 DA014718-05A1
Study First Received: October 2, 2007
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board
Malaysia: Ministry of Health

Keywords provided by Yale University:
buprenorphine
drug counseling
HIV risk reduction counseling

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
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
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014