NCT00725608

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

Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 339 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nonprobability sampling was done by invitation to volunteer.

Conditions

• Opioid-Related Disorders
• Opiate Dependence
• Drug Abuse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-07-30
• Last updated: 2017-03-03
• Results posted: 2012-03-23

Locations

1 site across 1 country: Austria