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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: | NCT00015340 |
The purpose of this study is the safety and efficacy of Burprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.
Condition | Intervention | Phase |
---|---|---|
Heroin Dependence Substance-Related Disorders |
Drug: Buprenorphine/naloxone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study |
Estimated Enrollment: | 0 |
Study Start Date: | November 1997 |
The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed CS 1008 A and B.
Ages Eligible for Study: | 18 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
completions of CS 1008 A/B
Exclusion Criteria:
Significant medical or psychiatric illness. Non-compliance with study procedures in CS 1008 A/B
Study ID Numbers: | NIDA-5-0013-14, Y01-5-0013-14 |
Study First Received: | April 18, 2001 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00015340 History of Changes |
Health Authority: | United States: Federal Government |
Heroin Dependence Heroin 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 |