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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00000302 |
Purpose
The purpose of this study is to compare liquid and tablet buprenorphine formulations.
| Condition | Intervention | Phase |
|---|---|---|
|
Heroin Dependence |
Drug: Buprenorphine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations |
| Estimated Enrollment: | 0 |
Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent.
Exclusion Criteria:
Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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-09260-5, P50-09260-5 |
| Study First Received: | September 20, 1999 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000302 History of Changes |
| Health Authority: | United States: Federal Government |
|
Buprenorphine Mental Disorders Heroin Dependence Narcotic Antagonists Substance-Related Disorders Central Nervous System Depressants |
Disorders of Environmental Origin Narcotics Peripheral Nervous System Agents Analgesics Opioid-Related Disorders Analgesics, Opioid |
|
Heroin Dependence Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Buprenorphine |
Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |