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Compliance Monitoring in Real Time During Opioid Substitution Treatment

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ClinicalTrials.gov Identifier: NCT01183130
Recruitment Status : Withdrawn (The technology planned to be used in the study got outdated and therefore the study will not be conducted according to the initial protocol.)
First Posted : August 17, 2010
Last Update Posted : April 1, 2015
Sponsor:
Information provided by:
Kuopio University Hospital

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Device: Compliance monitoring with electronic device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Compliance Monitoring in Real Time During Opioid Substitution Treatment
Study Start Date : August 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Compliance monitoring in real time
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
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.
Active Comparator: Compliance monitoring
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
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.



Primary Outcome Measures :
  1. The effectiveness of treatment (Treatment Outcomes Profile TOP) [ Time Frame: Every four weeks. ]
    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.


Secondary Outcome Measures :
  1. Patients´opinions about the treatment. [ Time Frame: Once when the study phase ends (after the 8 th study week). ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Opiate dependence
  • Suboxone treatment
  • Stable substitution medication dose

Exclusion Criteria:

  • Chaotic situation in life

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183130


Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Director: Ulrich Tacke, MD, PhD Kuopio University Hospital, University of Eastern Finland

Responsible Party: Ulrich Tacke, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01183130     History of Changes
Other Study ID Numbers: KUH5703434
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: August 2011

Keywords provided by Kuopio University Hospital:
opiate dependence
compliance monitoring
substitution treatment

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents