EHSO: Electronic Compliance Monitoring in Opioid Substitution Treatment

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01182402
• Collaborator: University of Eastern Finland (Other)
• Enrollment: 37
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Device: Compliance monitoring with electronic device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Electronic Compliance Monitoring in Opioid Substitution Treatment
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electronic compliance monitoring Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuopio University Hospital	Kuopio		Finland	70211

Sponsors and Collaborators

• Kuopio University Hospital
• University of Eastern Finland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01182402
• Other Study ID Numbers: KUH5703432
• First Posted: Aug 16, 2010
• Last Update Posted: Mar 22, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: opiate dependence; substitution treatment; unsupervised dosing; monitoring
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

No Results Posted as of Mar 22, 2011