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

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.

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Key information

Conditions

Buprenorphine Chemically-Induced Disorders Drug Abuse Mental Disorders Naloxone Narcotic-Related Disorders Opiate Dependence Opiate-related Disorders Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

0.4, 2, or 8 mg sublingual tablets

Other names: Subutex, buprenorphine high dose (BHD) generic (Arrow Laboratories), SCH 028444

Primary outcomes

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

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

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study title

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

Acronym: OPUS R

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jul 29, 2008
Registry last updated: Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed