Compliance Monitoring in Real Time During Opioid Substitution Treatment

Study Overview
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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.

Official Title
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Compliance Monitoring in Real Time During Opioid Substitution Treatment

Conditions
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Opiate Dependence

Intervention / Treatment
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* Device: Compliance monitoring with electronic device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Opiate dependence Suboxone treatment Stable substitution medication dose Exclusion Criteria: Chaotic situation in life

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compliance monitoring in real time<br>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. | Device: Compliance monitoring with electronic device<br>* 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.<br>|
| Active Comparator: Compliance monitoring<br>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. | Device: Compliance monitoring with electronic device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of treatment (Treatment Outcomes Profile TOP) | Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment. Interview covers the last four weeks so it can be done every four weeks. | Every four weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients´opinions about the treatment. | Questionnaire designed for this study to explore patients' opinions on the compliance monitoring and it's effect on the treatment and abuse and/or diversion of medications. | Once when the study phase ends (after the 8 th study week). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opiate dependence, compliance monitoring, substitution treatment