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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
Cincinnati MDRU |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00015028 |
Purpose
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. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-Related Disorders Substance-Related Disorders |
Drug: Buprenorphine/naloxone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone |
| Estimated Enrollment: | 0 |
| Study Start Date: | November 1996 |
This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.
Eligibility| Ages Eligible for Study: | 23 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Females of childbearing potential who do not agree to use a medically acceptable method of birth control. Acceptable methods include
Contacts and Locations
More Information
| Study ID Numbers: | NIDA-5-0012-1, Y01-5-0012-1 |
| Study First Received: | April 18, 2001 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00015028 History of Changes |
| Health Authority: | United States: Federal Government |
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Disease Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Naloxone Buprenorphine |
Pathologic Processes Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |