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

Drug Abuse Clinical Trial

— OPUS R  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723697
• Other study ID #: P05186
• Status: Completed
• Start date: May 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2023
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1307
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Buprenorphine
• Drug Abuse
• Naloxone
• Opiate Dependence
• Opiate-related Disorders
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• buprenorphine
0.4, 2, or 8 mg sublingual tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first visit, 6 months, and 12 months
Primary	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.	first visit, 6 months, and 12 months
Secondary	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.	first visit, 6 months, and 12 months