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Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)

NCT00725608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 339

Last updated 2017-03-03

Study results available
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Summary

The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.

Conditions

  • Opioid-Related Disorders
  • Opiate Dependence
  • Drug Abuse

Interventions

DRUG

buprenorphine/naloxone

2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone sublingual tablets; dosage and frequency are subject specific; subjects will receive treatment for up to 12 months

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Gabriele Fischer, Prof. Dr. · Medical University Vienna

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Austria

Study Locations

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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 NCT00725608 on ClinicalTrials.gov