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Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

NCT00723749 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 384

Last updated 2012-04-30

Study results available
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Summary

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

Conditions

  • Opioid-Related Disorders
  • Opiate Dependence
  • Drug Abuse

Interventions

DRUG

Buprenorphine/Naloxone

Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine \& 0.5 mg naloxone and 8 mg buprenorphine \& 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Markus Backmund, PD Dr. med. · Praxiszentrum im Tal (pit), Munich (Germany)

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

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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 NCT00723749 on ClinicalTrials.gov