Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients
Status:
Completed
Trial end date:
2014-07-30
Target enrollment:
Participant gender:
Summary
Background:
- Though the drug buprenorphine effectively treats dependence on opioids like heroin, some
abstinent patients relapse to use during treatment. This relapse may be triggered by
stress or stressful situations, and buprenorphine probably has no specific protective
effect in these situations. Buprenorphine probably also has no specific effect on
relapse to cocaine use.
- Research has shown that clonidine, a drug originally prescribed to treat high blood
pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse
to heroin and cocaine seeking in rats. Researchers are interested in studying whether a
combination of clonidine and buprenorphine may be more effective in preventing drug
relapse than administering one of the medications alone.
Objectives:
- To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is
more effective than placebo in preventing relapse to heroin or cocaine use.
Eligibility:
- Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking
treatment.
Design:
- The study will last up to 36 weeks, with four phases of treatment and a follow-up
evaluation. Three times a week, participants will be asked to report illicit drug use
and provide urine and breath samples. Throughout the study, participants will receive
individual counseling in weekly 40 60 minute sessions. Other samples and tests will be
scheduled as required by the study researchers.
- Patients will be stabilized on daily buprenorphine over the first 14 days of the study.
- Weeks 1 8: Participants will receive vouchers for regular substance-free urine samples.
Those who successfully complete this phase will continue to the next part of the study.
- Weeks 7 9: Participants will receive either clonidine or placebo along with the
buprenorphine. The dose of clonidine will be stabilized during this time.
- Weeks 9 22: Participants will continue to receive either clonidine or placebo along with
the buprenorphine. During this part of the study, participants will keep electronic
diaries to record drug use or craving and to record data on mood, stress levels, and
activity.
- Weeks 23 28: Participants will stop taking the clonidine or placebo, but will continue
the buprenorphine treatment. Participants will continue to keep electronic diaries.
- Weeks 29 36: Participants will have the choice of transferring to a community clinic
transfer or gradually reducing doses of buprenorphine to end the study.
- Participants will return for a follow-up visit and urine sample 6 months after the end
of the study.