NCT00723749

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

Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 384 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

Conditions

• Opioid-Related Disorders
• Opiate Dependence
• Drug Abuse

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-07-29
• Last updated: 2012-04-30
• Results posted: 2012-04-05