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.

Sponsor:

Information provided by:

Reckitt Benckiser Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT00723697

First received: July 25, 2008

Last updated: April 14, 2011

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 25, 2008
Last Updated Date	April 14, 2011
Start Date ^ICMJE	May 2007
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 14, 2011)	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.
Original Primary Outcome Measures ^ICMJE (submitted: July 25, 2008)	Percentage of subjects 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 ]
Change History	Complete list of historical versions of study NCT00723697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 14, 2011)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: July 25, 2008)	To study the impact of misuse on the clinical status of the patients treated by HDB; To describe the adverse events related to HDB [ Time Frame: first visit, 6 months, and 12 months ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
Official Title ^ICMJE	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
Brief 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.
Detailed Description	Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients addicted to opiates and requiring replacement treatment with Subutex (Schering-Plough) or BHD generic (Arrow laboratories)
Condition ^ICMJE	Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse
Intervention ^ICMJE	Drug: buprenorphine 0.4, 2, or 8 mg sublingual tablets Other Names: Subutex buprenorphine high dose (BHD) generic (Arrow Laboratories) SCH 028444
Study Group/Cohort (s)	Patients Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice. Intervention: Drug: buprenorphine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1307
Completion Date	February 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician. The patient must have been informed orally and in writing via the information notice and have signed it. Exclusion Criteria: Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00723697
Other Study ID Numbers ^ICMJE	P05186
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Reckitt Benckiser Pharmaceuticals Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Reckitt Benckiser Pharmaceuticals Inc.
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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