Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED) (OPUS R)
This study has been completed.
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First received: July 25, 2008
Last updated: April 14, 2011
Last verified: July 2010
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 Design:||Observational Model: Cohort
Time Perspective: 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|
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Further study details as provided by Indivior Inc.:
Primary Outcome Measures:
- Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
- Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.
Secondary Outcome Measures:
- Number of Patients Reporting Clinical Consequences of Engaging in Misuse [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: No ]Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.
|Study Start Date:||May 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
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.
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