Compliance Monitoring in Real Time During Opioid Substitution Treatment

NCT ID: NCT01183130

Last Updated: 2015-04-01

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Opiate Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Compliance monitoring in real time

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.

Group Type EXPERIMENTAL

Compliance monitoring with electronic device

Intervention Type DEVICE

Electronic compliance monitoring with monitoring device (Pharma DDSi, Stora Enso) is used in control group (n=6) and device with mobile phone in intervention group (n=6). Patients in intervention group send every day the information of their medication intakes with the mobile phone to the clinic. This intervention is tested in pilot study (n=2-3) before the actual study begins.

Compliance monitoring

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.

Group Type ACTIVE_COMPARATOR

Compliance monitoring with electronic device

Intervention Type DEVICE

Electronic compliance monitoring with monitoring device (Pharma DDSi, Stora Enso) is used in control group (n=6) and device with mobile phone in intervention group (n=6). Patients in intervention group send every day the information of their medication intakes with the mobile phone to the clinic. This intervention is tested in pilot study (n=2-3) before the actual study begins.

Interventions

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Compliance monitoring with electronic device

Electronic compliance monitoring with monitoring device (Pharma DDSi, Stora Enso) is used in control group (n=6) and device with mobile phone in intervention group (n=6). Patients in intervention group send every day the information of their medication intakes with the mobile phone to the clinic. This intervention is tested in pilot study (n=2-3) before the actual study begins.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Opiate dependence
* Suboxone treatment
* Stable substitution medication dose

Exclusion Criteria

* Chaotic situation in life
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuopio University Hospital

Principal Investigators

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Ulrich Tacke, MD, PhD

Role: STUDY_DIRECTOR

Kuopio University Hospital, University of Eastern Finland

Other Identifiers

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KUH5703434

Identifier Type: -

Identifier Source: org_study_id

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