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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: | NCT00000320 |
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 |
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Opioid-Related Disorders |
Drug: Buprenorphine formulation: liquid vs. tablet |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution |
Enrollment: | 120 |
Study Start Date: | October 1997 |
Study Completion Date: | August 1999 |
Primary Completion Date: | August 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1; liquid formulation: Active Comparator
liquid formulation
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Drug: Buprenorphine formulation: liquid vs. tablet
random assignment to liquid buprenorphine or tablet buprenorphine
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2; tablet formulation: Active Comparator
tablet formulation
|
Drug: Buprenorphine formulation: liquid vs. tablet
random assignment to liquid buprenorphine or tablet buprenorphine
|
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
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.
United States, California | |
Friends Research Institute | |
Los Angeles, California, United States, 90025 |
Principal Investigator: | Walter Ling, M.D. | Friends Research Institute, Inc. |
Responsible Party: | Friends Research Institute ( Walter Ling, M.D. ) |
Study ID Numbers: | NIDA-10068-1, R01-10068-1 |
Study First Received: | September 20, 1999 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00000320 |
Health Authority: | United States: Federal Government |
Buprenorphine Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders |
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |