Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED) (OPUS R)
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|ClinicalTrials.gov Identifier: NCT00723697|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : May 10, 2011
Last Update Posted : May 10, 2011
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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 or disease||Intervention/treatment|
|Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse||Drug: buprenorphine|
Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
|Study Type :||Observational|
|Actual Enrollment :||1307 participants|
|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|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
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
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 ]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 ]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 ]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.
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