Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing|
- Retention Rate [ Time Frame: month 6, month 12 ] [ Designated as safety issue: No ]The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study
- Dosing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: day 1, month 6, month 12 ] [ Designated as safety issue: No ]One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.
- Dispensing of Suboxone (Buprenorphine Plus Naloxone) [ Time Frame: month 6, month 12 ] [ Designated as safety issue: No ]Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)
|Study Start Date:||May 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus 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
Other Name: Suboxone, SCH 000484
Nonprobability sampling was done by invitation to volunteer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725608
|(Multiple sites in Austria) => Coordinating CRO: H&P GmbH|
|Vienna, Austria, 1070|
|Principal Investigator:||Gabriele Fischer, Prof. Dr.||Medical University Vienna|