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

NCT00723697 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1307

Last updated 2023-03-20

Study results available
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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.

Conditions

  • Buprenorphine
  • Naloxone
  • Opiate-related Disorders
  • Opiate Dependence
  • Drug Abuse

Interventions

DRUG

buprenorphine

0.4, 2, or 8 mg sublingual tablets

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-02-28
Completion
2010-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723697 on ClinicalTrials.gov