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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00295308 |
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.
Condition | Intervention | Phase |
---|---|---|
Opioid-Related Disorders |
Drug: Clonidine Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients |
Estimated Enrollment: | 300 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Clonidine
clonidine up to 0.3 mg/day oral
|
2: Placebo Comparator |
Drug: placebo
oral capsules daily
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenzie L Preston, PhD | 410-550-1639 | kpreston@intra.nida.nih.gov |
United States, Maryland | |
NIDA Intramural Research Program | Recruiting |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Kenzie L Preston, PhD | NIDA Intramural Research Program |
Responsible Party: | National Institute on Drug Abuse ( Kenzie L. Preston, Ph.D., Principal Investigator ) |
Study ID Numbers: | NIDAIRP 407, Z01 DA 000500 |
Study First Received: | February 22, 2006 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00295308 |
Health Authority: | United States: Federal Government |
clonidine relapse buprenorphine opioid abstinence opioid dependence |
Buprenorphine Mental Disorders Clonidine Substance-Related Disorders |
Disorders of Environmental Origin Opioid-Related Disorders Recurrence |
Sympatholytics Neurotransmitter Agents Disease Attributes Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Narcotic Antagonists Central Nervous System Depressants Narcotics Cardiovascular Agents |
Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |