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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Colorado at Denver and Health Sciences Center |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00000327 |
The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
Condition | Intervention | Phase |
Heroin Dependence Opioid-Related Disorders |
Drug: Heroin Dependence |
Phase II |
MedlinePlus related topics: | Heroin |
Drug Information available for: | Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Crossover Assignment |
Official Title: | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) |
Estimated Enrollment: | 0 |
Study Start Date: | June 1997 |
Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tabelt (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
Ages Eligible for Study: | 18 Years to 62 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Exclusion Criteria:
Individuals with evidence of an active DSM-IV Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
United States, Colorado | |||||
University of Colorado Health Sciences Center | |||||
Denver, Colorado, United States, 80206 |
National Institute on Drug Abuse (NIDA) |
University of Colorado at Denver and Health Sciences Center |
Principal Investigator: | Leslie Amass, Ph.D. | University of Colorado at Denver and Health Sciences Center |
Amass, L., Kamien, J.H., and Mikulich, S.K. Efficacy of and preference for 3-day vs daily dosing with the buprenorphine-naloxone combination tablet. presented to the 1998 Meeting of the College on Problems of Drug Dependence. Scottsdate, AZ (6/13-18). Presenting at CPDD 1998
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Study ID Numbers: | NIDA-11160-2, R01-11160-2 |
First Received: | September 20, 1999 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00000327 |
Health Authority: | United States: Federal Government |
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