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| Sponsor: | University of California, Los Angeles |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00032955 |
Purpose
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.
| Condition | Intervention | Phase |
|---|---|---|
|
Heroin Dependence Morphine Dependence Substance Withdrawal Syndrome |
Drug: Buprenorphine/naloxone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification |
| Estimated Enrollment: | 163 |
| Study Start Date: | February 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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| Betty Ford Center | |
| Rancho Mirage, California, United States, 92270 | |
| United States, Florida | |
| The Center For Drug-Free Living | |
| Orlando, Florida, United States, 32801 | |
| Operation PAR, Inc. | |
| Pinellas Park, Florida, United States, 33781 | |
| United States, Michigan | |
| Self Help Addiction Rehabilitation (SHAR), Inc. | |
| Detroit, Michigan, United States, 48208 | |
| United States, New York | |
| Phoenix House | |
| New York, New York, United States, 10023 | |
| United States, Ohio | |
| Maryhaven, Inc. | |
| Columbus, Ohio, United States, 43207 | |
| Principal Investigator: | Walter Ling, M.D. | Los Angeles Treatment Research Center |
More Information
| Responsible Party: | Walter Ling, M.D., University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00032955 History of Changes |
| Obsolete Identifiers: | NCT00015392 |
| Other Study ID Numbers: | NIDA-CTN-0001-1 |
| Study First Received: | April 5, 2002 |
| Last Updated: | April 13, 2010 |
| Health Authority: | United States: Federal Government |
|
Heroin Dependence Morphine Dependence Substance Withdrawal Syndrome Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Naloxone Clonidine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |