Study Stopped
The technology planned to be used in the study got outdated and therefore the study will not be conducted according to the initial protocol.
Compliance Monitoring in Real Time During Opioid Substitution Treatment
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 1, 2015
August 1, 2011
8 months
August 9, 2010
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Patients´opinions about the treatment.
Once when the study phase ends (after the 8 th study week).
Study Arms (2)
Compliance monitoring in real time
EXPERIMENTALPatients 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.
Compliance monitoring
ACTIVE COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Opiate dependence
- Suboxone treatment
- Stable substitution medication dose
You may not qualify if:
- Chaotic situation in life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ulrich Tacke, MD, PhD
Kuopio University Hospital, University of Eastern Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 9, 2010
First Posted
August 17, 2010
Study Start
August 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 1, 2015
Record last verified: 2011-08