Electronic Compliance Monitoring in Opioid Substitution Treatment (EHSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01182402
Recruitment Status : Completed
First Posted : August 16, 2010
Last Update Posted : March 22, 2011
University of Eastern Finland
Information provided by:
Kuopio University Hospital

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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 : September 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. The effectiveness of treatment (Treatment Outcomes Profile TOP) [ Time Frame: 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. [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01182402

Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland

Responsible Party: Ulrich Tacke, Kuopio University Hospital Identifier: NCT01182402     History of Changes
Other Study ID Numbers: KUH5703432
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Keywords provided by Kuopio University Hospital:
opiate dependence
substitution treatment
unsupervised dosing

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders