Clinical trial NCT00539123: Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
Official title: Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Dependence
Keywords: buprenorphine
drug counseling
HIV risk reduction counseling
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-10-04
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: TREATMENT

Brief summary: 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.

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 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 buprenorphine and counseling remained in treatment for 6 months; only 28% avoided relapse to heroin; and treatment reduced drug- but not sex-related HIV risk behaviors. In actual clinical practice in Malaysia and the U.S. buprenorphine treatment effectiveness may be even less, because buprenorphine is provided with relatively minimal psychosocial services (often brief physician management (PM) alone, without additional counseling), and without additional behavioral interventions or contingency management. Hence, we propose a follow up study to evaluate whether standard buprenorphine treatment (consisting of buprenorphine provision, PM, and non-contingent provision of take-home doses of buprenorphine, NCB) is sufficient or whether one or a combination of two behavioral treatments--behavioral drug and HIV risk reduction counseling (BDRC) or abstinence-contingent take-home buprenorphine (ACB)-improve its efficacy. 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 (NCB), 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 PM with NCB, PM with ACB, PM with BDRC and NCB, or PM with BDRC and ACB (weeks 3-26). Primary outcome measures include reductions in heroin use (percent days abstinent, proportion of opiate-negative urine tests) and reductions in drug- and sex-related HIV risk behaviors. Data analyses will focus on the intention-to treat sample. The study results will inform practice guidelines and policies regarding buprenorphine treatment.

Eligibility 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

Primary outcomes:
measure: reductions in heroin use
timeFrame: 26 weeks
measure: reductions in drug- and sex-related HIV risk
timeFrame: 26 weeks
Secondary outcomes:
measure: retention
timeFrame: 26 weeks
measure: reductions in other illicit drug use
timeFrame: 26 weeks
measure: changes in functional status
timeFrame: 26 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Muar
country: Malaysia
facility: Substance Abuse Research Center
state: Johor
Study officials:
affiliation: Yale University
name: Richard S. Schottenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Substance Abuse Research Center, Muar
name: Mahmud Mazlan, MD
role: STUDY_DIRECTOR
References: