Opiate Dependence Clinical Trial
— EHSOOfficial title:
Electronic Compliance Monitoring in Opioid Substitution Treatment
Verified date | March 2011 |
Source | Kuopio University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Finland | Kuopio University Hospital | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital | University of Eastern Finland |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effectiveness of treatment (Treatment Outcomes Profile TOP) | Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment. | Every two months. | No |
Secondary | Patients´opinions about the treatment. | 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. | Once when the study phase ends (after four months). | Yes |
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