Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Buprenorphine; Naloxone; Opiate-Related Disorders; Opiate Dependence; Drug Abuse
Intervention: buprenorphine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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.
Clinical Details
Official title: Etude Observationnelle Prospective de l'Utilisation en Situation RéElle 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
Study design: Cohort, Prospective
Primary outcome: Percentage of subjects reporting misuse (injection, sniffing, dose fractionation, modification of prescribed doses, and combination with psychotropic agents)
Secondary outcome: To study the impact of misuse on the clinical status of the patients treated by HDB; To describe the adverse events related to HDB
Detailed description:
Approximately 380 physicians will participate in this study. Patients will be enrolled in
chronological order of consultations.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Coordinating Location, Levallois-Perret Cedex, France; Recruiting
Additional Information
Starting date: May 2007
Ending date: December 2009
Last updated: October 20, 2008
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