The purpose of the study is to determine whether clonidine, given to abstinent patients maintainedon buprenorphine, prevents relapse to opioid use more effectively than placebo...
Date First Received: February 22, 2006
Last Updated: June 19, 2008
Verified by: National Institute on Drug Abuse (NIDA), June 2008
Clinical Trial Phase: Phase 1 | Start Date: September 2006
Overall Status: Recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients”
Condition Keyword(s):
Intervention(s):
The purpose of the study is to determine whether clonidine, given to abstinent patients maintainedon buprenorphine, prevents relapse to opioid use more effectively than placebo.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Study Primary Completion Date: September 2010
Intervention(s) in this Clinical Trial
- Drug: Clonidine
- clonidine up to 0.3 mg/day oral
- Drug: placebo
- oral capsules daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Opiate-negative urine screens
- Time Frame: 38 weeks
Safety Issue?: No
- Time Frame: 38 weeks
Secondary Measures
- HIV risk behaviors
- Time Frame: 38 weeks
Safety Issue?: No
- Time Frame: 38 weeks
- craving
- Time Frame: 18 weeks
Safety Issue?: No
- Time Frame: 18 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- physical dependence on illicit opioids
- seeking treatment for opioid dependence
- able to attend clinic 7 days/week
Exclusion Criteria:
- any medical or psychiatric condition that would compromise participation in the study or contraindicate administration of clonidine or buprenorphine
- pregnancy or breast feeding
- cognitive impairment that would cause inability to give informed consent
- allergy or intolerance to buprenorphine or clonidine
- currently taking any medications that are contraindicated with clonidine or buprenorphine
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
Kenzie L Preston, PhD Principal Investigator NIDA Intramural Research Program
Overall Contact: Kenzie L Preston, PhD 410-550-1639 kpreston@intra.nida.nih.gov
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00295308
Study ID Number: NIDAIRP 407
ClinicalTrials.gov Identifier: NCT00295308
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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