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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00000320 |
Purpose
The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
| Condition | Intervention | Phase |
|
Opioid-Related Disorders |
Drug: Buprenorphine |
Phase II |
| ChemIDplus related topics: | Buprenorphine Buprenorphine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Crossover Assignment |
| Official Title: | Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution |
| Estimated Enrollment: | 0 |
| Study Start Date: | October 1997 |
1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria:
Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
Contacts and Locations| United States, California | |||||
| Friends Research Institute | |||||
| Los Angeles, California, United States, 90025 | |||||
| Principal Investigator: | Walter Ling, M.D. | Friends Research Institute, Inc. |
More Information
| Study ID Numbers: | NIDA-10068-1, R01-10068-1 |
| First Received: | September 20, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000320 |
| Health Authority: | United States: Federal Government |
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