Electronic Compliance Monitoring in Opioid Substitution Treatment

Opiate Dependence Clinical Trial

— EHSO  

Official title:

Electronic Compliance Monitoring in Opioid Substitution Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182402
• Other study ID #: KUH5703432
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: March 21, 2011
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Device:
• Compliance monitoring with electronic device
Patients get all their unsupervised substitution medication doses in electronic monitoring devices during the study. Daily dose of the drug is possible to get from the device in given time points and in the meantime device is locked.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of treatment (Treatment Outcomes Profile TOP)	Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.	Every two months.	No
Secondary	Patients´opinions about the treatment.	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.	Once when the study phase ends (after four months).	Yes