Electronic Compliance Monitoring in Opioid Substitution Treatment (EHSO)

This study has been completed.
Sponsor:
Collaborator:
University of Eastern Finland
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01182402
First received: August 11, 2010
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

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 Intervention
Opiate Dependence
Device: Compliance monitoring with electronic device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Electronic Compliance Monitoring in Opioid Substitution Treatment

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • The effectiveness of treatment (Treatment Outcomes Profile TOP) [ Time Frame: Every two months. ] [ Designated as safety issue: No ]
    Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.


Secondary Outcome Measures:
  • Patients´opinions about the treatment. [ Time Frame: Once when the study phase ends (after four months). ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 37
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182402

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
University of Eastern Finland
  More Information

No publications provided

Responsible Party: Ulrich Tacke, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01182402     History of Changes
Other Study ID Numbers: KUH5703432
Study First Received: August 11, 2010
Last Updated: March 21, 2011
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014