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

Indivior

Status: Completed

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

Treatments: Drug: buprenorphine

Study type: Observational

Funder types: Industry

Identifiers

NCT00723697

P05186

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,307 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,307 participants in 1 patient group

Patients

Description:

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

Treatment:

Drug: buprenorphine