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Completed

NCT Number: NCT01182402

Electronic Compliance Monitoring in Opioid Substitution Treatment

The purpose of this study is to improve unsupervised dosing of opioid substitution medications. The aim of the study is to examine whether electronic compliance monitoring provides some advantages to patients'treatment and what kind of patients especially benefit from monitoring. We would also like to know if electronic compliance monitoring can prevent the abuse/diversion of medications and how implementing this method to wider treatment facilities succeeds.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70211, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • opiate dependence F11.22 according to ICD-10
  • Suboxone treatment
  • the duration of substitution treatment before study at least one month
  • stable medication dose

Exclusion criteria

  • unstable situation in life according to treatment staff's opinions

Treatment and study plan

Compliance monitoring with electronic device

Device

Patients get all their unsupervised substitution medication doses in electronic monitoring devices during the study. Daily dose of the drug is possible to get from the device in given time points and in the meantime device is locked.

Primary outcomes

  1. The effectiveness of treatment (Treatment Outcomes Profile TOP)

    Time frame: Every two months.

    Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.

Secondary outcomes

  1. Patients´opinions about the treatment.

    Time frame: Once when the study phase ends (after four months).

    Questionnaire designed for this study to explore patients' opinions on the compliance monitoring and it's effect on their treatment and abuse and/or diversion of medications.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Acronym: EHSO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 16, 2010
Registry last updated
Mar 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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