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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: | NCT00000344 |
The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.
Condition | Intervention | Phase |
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Opioid-Related Disorders |
Drug: Buprenorphine/naloxone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind |
Official Title: | Trial of Buprenorphine/Naloxone for Treatment of Opiate Dependence |
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. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria:
Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
United States, California | |
Friends Research Institute | |
Los Angeles, California, United States, 90025 |
Principal Investigator: | Walter Ling, M.D. | Friends Research Institute, Inc. |
Study ID Numbers: | NIDA-3-0010-9, Y01-3-0010-9 |
Study First Received: | September 20, 1999 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00000344 |
Health Authority: | United States: Federal Government |
Buprenorphine Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Opioid-Related Disorders Naloxone |
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 |