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

Completed

• Conditions: Opiate-related Disorders; Opiate Dependence; Buprenorphine; Naloxone; Drug Abuse
• Interventions: Drug: buprenorphine

• Registration Number: NCT00723697
• Lead Sponsor: Indivior Inc.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-04-14
• Results First Submitted QC: 2011-04-14
• Results First Posted: 2011-05-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1307

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	buprenorphine	Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)	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.	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

Name	Time	Method
Number of Patients Reporting Clinical Consequences of Engaging in Misuse	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.