Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Schering-Plough |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00723697 |
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.
Condition | Intervention |
---|---|
Buprenorphine Naloxone Opiate-Related Disorders Opiate Dependence Drug Abuse |
Drug: buprenorphine |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Etude Observationnelle Prospective de l'Utilisation en Situation Reelle Prospective Real Situation Observational Study of Subutex® or Its Buprenorphine High Dose Generic (BHD) in the Replacement Treatment of Major Opiate Dependence: Following Parameters With Respect to Misuse and Pharmacovigilance |
Estimated Enrollment: | 1250 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Patients
Patients addicted to opiates and requiring replacement treatment
|
Drug: buprenorphine
0.4, 2, or 8 mg sublingual tablets
|
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05186 |
Study First Received: | July 25, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00723697 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Subutex |
Buprenorphine Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders |
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 |