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Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED) — OPUS R  

Drug Abuse Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00723697
Study type Observational
Source Indivior Inc.
Contact
Status Completed
Phase
Start date May 2007
Completion date February 2010
View Details
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