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

Indivior Inc.1,307 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

1,307

Conditions

Buprenorphine Naloxone Opiate-related Disorders Opiate Dependence Drug Abuse

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

Time frame: first visit, 6 months, and 12 months

Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.

Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.

Time frame: first visit, 6 months, and 12 months

Secondary Outcomes

Number of Patients Reporting Clinical Consequences of Engaging in Misuse

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.

Time frame: first visit, 6 months, and 12 months