Compliance Monitoring in Real Time During Opioid Substitution Treatment

Not Applicable

Withdrawn

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

• Registration Number: NCT01183130
• Lead Sponsor: Kuopio University Hospital

Brief Summary

The aim of the study is to examine whether electronic compliance monitoring in real time could offer some advantages compared to normal electronic monitoring in opioid substitution treatment. The investigators would also like know whether this method could enable the quick detection of possible problems in medication intakes and/or prevent the abuse or diversion of substitution medications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Status Verified: 2011-08
• Study Start: 2011-08
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Opiate dependence
• Suboxone treatment
• Stable substitution medication dose

Exclusion Criteria

• Chaotic situation in life

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compliance monitoring	Compliance monitoring with electronic device	Patients get their opioid substitution medications in electronic compliance monitoring devices. Information of their medication intakes will be reviewed during the weekly visits to the clinic.
Compliance monitoring in real time	Compliance monitoring with electronic device	Patients get their opioid substitution medications in electronic compliance monitoring devices and send information of their medication intakes with mobile phone to the clinic every day during the two month study period.

Primary Outcome Measures

Name	Time	Method
The effectiveness of treatment (Treatment Outcomes Profile TOP)	Every four weeks.	Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment. Interview covers the last four weeks so it can be done every four weeks.

Secondary Outcome Measures

Name	Time	Method
Patients´opinions about the treatment.	Once when the study phase ends (after the 8 th study week).	Questionnaire designed for this study to explore patients' opinions on the compliance monitoring and it's effect on the treatment and abuse and/or diversion of medications.