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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00032968 |
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.
Condition | Intervention | Phase |
---|---|---|
Heroin Dependence Morphine Dependence Substance Withdrawal Syndrome |
Drug: Buprenorphine/naloxone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Buprenorphine/Naloxone Versus Clonidine For Out-Patient Opiate Detoxification |
Estimated Enrollment: | 341 |
Study Start Date: | January 2001 |
Study Completion Date: | August 2002 |
Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Use of one of the following acceptable methods of birth control by female patients of childbearing potential:
Exclusion Criteria:
United States, California | |
Aegis Medical Systems, Inc. | |
Oxnard, California, United States, 93033 | |
Haight-Ashbury Free Clinic | |
Berkeley, California, United States, 94704 | |
United States, Indiana | |
Midtown Community Mental Health Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, New Jersey | |
UMDNJ - Robert Wood Johnson Medical School | |
Piscataway, New Jersey, United States, 08854 | |
United States, New York | |
Addiction Research and Treatment Corp | |
Brooklyn, New York, United States, 11201 | |
Bellevue | |
New York, New York, United States, 10016 | |
United States, Oregon | |
Kaiser Permanente Northwest, Division of Addiction | |
Portland, Oregon, United States, 97227 |
Principal Investigator: | Walter Ling, M.D. | Los Angeles Treatment Research Center |
Study ID Numbers: | NIDA-CTN-0002-1 |
Study First Received: | April 5, 2002 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00032968 |
Health Authority: | United States: Federal Government |
Buprenorphine Substance Withdrawal Syndrome Morphine Dependence Mental Disorders Heroin Dependence |
Clonidine Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders Naloxone |
Disease Physiological Effects of Drugs Narcotic Antagonists Central Nervous System Depressants Narcotics Pharmacologic Actions Pathologic Processes |
Sensory System Agents Syndrome Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |