CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 384 enrolled
Drug / intervention
Buprenorphine/Naloxonedrug
Likely dose
Buprenorphine/Naloxone 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00723749
NCT00723749N/ACompleted
CompareCT.gov

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.

Indivior Inc.·observational·Posted Jul 29, 2008·Updated Apr 30, 2012

In Brief

An observational study evaluating Buprenorphine/Naloxone for Opioid-Related Disorders and 2 related conditions. Completed, enrolled 384 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders, Opiate Dependence, Drug Abuse
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartMar 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

Buprenorphine/Naloxonedrug

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.