At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,307 enrolled
Drug / intervention
buprenorphinedrug
Likely dose
buprenorphine 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating buprenorphine for Buprenorphine and 4 related conditions. Completed, enrolled 1,307 participants.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBuprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence, Drug Abuse
Countries--
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedJul 2008
Primary CompletionFeb 2010
TodayJul 2026
First PostedJul 29, 2008
Enrollment StartMay 1, 2007
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago
Interventions
buprenorphinedrug
0.4, 2, or 8 mg sublingual tablets