Electronic Compliance Monitoring in Opioid Substitution Treatment

NCT ID: NCT01182402

Last Updated: 2011-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Opiate Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Compliance monitoring with electronic device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH5703432

Identifier Type: -

Identifier Source: org_study_id

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