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

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.

• buprenorphine (Drug), also known as Subutex, buprenorphine high dose (BHD) generic (Arrow Laboratories), SCH 028444: 0.4, 2, or 8 mg sublingual tablets

Primary outcomes

• 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 outcomes

• 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.

Sex: All

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

Participant flow

Outcome results

• Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) (Primary), Number, participants: Patients 131 (30.61 to 39.57)
• Number of Patients Reporting Clinical Consequences of Engaging in Misuse (Secondary), Number, participants: Patients at First Visit 41; Patients at 6 Month Visit 29; Patients at 12 Month Visit 31
• Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. (Primary), Number, participants: Patients 206

Adverse events

Serious adverse events by term