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

Completed

• Conditions: Opioid-Related Disorders; Drug Abuse; Opiate Dependence
• Interventions: Drug: buprenorphine/naloxone

• Registration Number: NCT00725608
• Lead Sponsor: Indivior Inc.

Brief 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2011-10-18
• Results First Submitted QC: 2012-02-12
• Results First Posted: 2012-03-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

• All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
• Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.

Exclusion Criteria

• According to product information
• In accordance with the product information pregnant women will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	buprenorphine/naloxone	Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)

Primary Outcome Measures

Name	Time	Method
Retention Rate	month 6, month 12	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

Secondary Outcome Measures

Name	Time	Method
Dispensing of Suboxone (Buprenorphine Plus Naloxone)	month 6, month 12	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)
Dosing of Suboxone (Buprenorphine Plus Naloxone)	day 1, month 6, month 12	One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.

Trial Locations

Locations (1)

(Multiple sites in Austria) => Coordinating CRO: H&P GmbH; 🇦🇹 Vienna, Austria