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Compliance Monitoring in Real Time During Opioid Substitution Treatment

Primary Purpose

Opiate Dependence

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compliance monitoring with electronic device
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opiate Dependence focused on measuring opiate dependence, compliance monitoring, substitution treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Opiate dependence
  • Suboxone treatment
  • Stable substitution medication dose

Exclusion Criteria:

  • Chaotic situation in life

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Compliance monitoring in real time

    Compliance monitoring

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    August 9, 2010
    Last Updated
    March 31, 2015
    Sponsor
    Kuopio University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01183130
    Brief Title
    Compliance Monitoring in Real Time During Opioid Substitution Treatment
    Official Title
    Compliance Monitoring in Real Time During Opioid Substitution Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Withdrawn
    Why 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.
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    April 2012 (Anticipated)
    Study Completion Date
    April 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kuopio University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opiate Dependence
    Keywords
    opiate dependence, compliance monitoring, substitution treatment

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Compliance monitoring in real time
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Compliance monitoring
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Compliance monitoring with electronic device
    Intervention Description
    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 Measure Information:
    Title
    The effectiveness of treatment (Treatment Outcomes Profile TOP)
    Description
    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.
    Time Frame
    Every four weeks.
    Secondary Outcome Measure Information:
    Title
    Patients´opinions about the treatment.
    Description
    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.
    Time Frame
    Once when the study phase ends (after the 8 th study week).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Opiate dependence Suboxone treatment Stable substitution medication dose Exclusion Criteria: Chaotic situation in life
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ulrich Tacke, MD, PhD
    Organizational Affiliation
    Kuopio University Hospital, University of Eastern Finland
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Compliance Monitoring in Real Time During Opioid Substitution Treatment

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