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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: | NCT00000243 |
Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.
Condition | Intervention |
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Opioid-Related Disorders |
Drug: Buprenorphine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Transitioning Patients From Methadone to Buprenorphine/Naloxone for Treating Opioid Dependence |
Estimated Enrollment: | 16 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | January 2004 |
Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins University (BPRU) Bayview Campus | |
Baltimore, Maryland, United States, 21224 6823 |
Principal Investigator: | Eric C. Strain, MD | Johns Hopkins University |
Study ID Numbers: | NIDA-08045-1, R01-08045-1, DPMC |
Study First Received: | September 20, 1999 |
Last Updated: | March 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00000243 |
Health Authority: | United States: Food and Drug Administration |
Methadone 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 |