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Electronic Compliance Monitoring in Opioid Substitution Treatment (EHSO)

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Compliance monitoring with electronic device
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opiate Dependence focused on measuring opiate dependence, substitution treatment, unsupervised dosing, monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electronic compliance monitoring

Arm Description

Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study.

Outcomes

Primary Outcome Measures

The effectiveness of treatment (Treatment Outcomes Profile TOP)
Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.

Secondary Outcome Measures

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.

Full Information

First Posted
August 11, 2010
Last Updated
March 21, 2011
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01182402
Brief Title
Electronic Compliance Monitoring in Opioid Substitution Treatment
Acronym
EHSO
Official Title
Electronic Compliance Monitoring in Opioid Substitution Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opiate dependence, substitution treatment, unsupervised dosing, monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic compliance monitoring
Arm Type
Experimental
Arm Description
Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study.
Intervention Type
Device
Intervention Name(s)
Compliance monitoring with electronic device
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Description
Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
Time Frame
Every two months.
Secondary Outcome Measure Information:
Title
Patients´opinions about the treatment.
Description
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.
Time Frame
Once when the study phase ends (after four months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland

12. IPD Sharing Statement

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Electronic Compliance Monitoring in Opioid Substitution Treatment

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