Compliance Monitoring in Real Time During Opioid Substitution Treatment - Full Text View

Purpose

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	Intervention
Opiate Dependence	Device: Compliance monitoring with electronic device

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Compliance Monitoring in Real Time During Opioid Substitution Treatment

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:

The effectiveness of treatment (Treatment Outcomes Profile TOP) [ Time Frame: Every four weeks. ] [ Designated as safety issue: No ]
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. [ Time Frame: Once when the study phase ends (after the 8 th study week). ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	15
Study Start Date:	August 2011
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Opiate dependence
Suboxone treatment
Stable substitution medication dose

Exclusion Criteria:

Chaotic situation in life

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183130

Sponsors and Collaborators

Kuopio University Hospital

Investigators

Study Director:

Ulrich Tacke, MD, PhD

Kuopio University Hospital, University of Eastern Finland

More Information

No publications provided

Responsible Party:	Ulrich Tacke, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT01183130 History of Changes
Other Study ID Numbers:	KUH5703434
Study First Received:	August 9, 2010
Last Updated:	August 18, 2011
Health Authority:	Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:

opiate dependence
compliance monitoring
substitution treatment

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on October 17, 2012