Electronic Compliance Monitoring in Opioid Substitution Treatment

Not Applicable

Completed

• Conditions: Opiate Dependence
• Interventions: Device: Compliance monitoring with electronic device

• Registration Number: NCT01182402
• Lead Sponsor: Kuopio University Hospital

Brief Summary

The purpose of this study is to improve unsupervised dosing of opioid substitution medications. The aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. We would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-13
• Study First Posted: 2010-08-16
• Study Start: 2010-09
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• opiate dependence F11.22 according to ICD-10
• Suboxone treatment
• the duration of substitution treatment before study at least one month
• stable medication dose

Exclusion Criteria

• unstable situation in life according to treatment staff's opinions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electronic compliance monitoring	Compliance monitoring with electronic device	Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study.

Primary Outcome Measures

Name	Time	Method
The effectiveness of treatment (Treatment Outcomes Profile TOP)	Every two months.	Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.

Secondary Outcome Measures

Name	Time	Method
Patients´opinions about the treatment.	Once when the study phase ends (after four months).	Questionnaire designed for this study to explore patients' opinions on the compliance monitoring and it's effect on their treatment and abuse and/or diversion of medications.

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland