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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) New York MDRU |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00015171 |
The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.
Condition | Intervention | Phase |
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Heroin Dependence Substance-Related Disorders |
Drug: Buprenorphine/naloxone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence |
Estimated Enrollment: | 0 |
Study Start Date: | April 1996 |
The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.
Ages Eligible for Study: | 18 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age
Exclusion Criteria:
Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence
Study ID Numbers: | NIDA-5-0013-1, Y01-5-0013-1 |
Study First Received: | April 18, 2001 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00015171 History of Changes |
Health Authority: | United States: Federal Government |
Heroin Dependence Narcotic Antagonists Disorders of Environmental Origin Central Nervous System Depressants Narcotics Opioid-Related Disorders Naloxone |
Buprenorphine Mental Disorders Substance-Related Disorders Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
Heroin Dependence Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Naloxone |
Buprenorphine Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |