Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00539123 |
Other study ID # |
0506000082 |
Secondary ID |
R01DA014718-05A1 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 2007 |
Est. completion date |
August 2012 |
Study information
Verified date |
June 2021 |
Source |
Yale University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.