Electronic Compliance Monitoring in Opioid Substitution Treatment (EHSO)
This study has been completed.
Sponsor:
Kuopio University Hospital
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
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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 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 October 17, 2012
