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NCT01183130 Clinical Trial

Compliance Monitoring in Real Time During Opioid Substitution Treatment

Opiate Dependence Clinical Trial

Official title:
Compliance Monitoring in Real Time During Opioid Substitution Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01183130
Other study ID # KUH5703434
Secondary ID
Status Withdrawn
Phase N/A
First received August 9, 2010
Last updated March 31, 2015
Start date August 2011
Est. completion date April 2012

Study information
Verified date August 2011
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Opiate dependence

- Suboxone treatment

- Stable substitution medication dose

Exclusion Criteria:

- Chaotic situation in life

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• Compliance monitoring with electronic device
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kuopio University Hospital

Outcome
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. Interview covers the last four weeks so it can be done every four weeks. Every four weeks. 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 the treatment and abuse and/or diversion of medications. Once when the study phase ends (after the 8 th study week). Yes
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