Electronic Compliance Monitoring in Opioid Substitution Treatment

NCT01182402 | Completed

• 1 other identifier: KUH5703432
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opiate Dependence

Keywords

opiate dependence; substitution treatment; unsupervised dosing; monitoring

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.

  Every two months.

Secondary Outcomes (1)

• Patients´opinions about the treatment.

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

Study Arms (1)

Electronic compliance monitoring

EXPERIMENTAL

Suboxone treated patients in Kuopio city area get their unsupervised Suboxone doses in electronic compliance monitoring devices during the 4 month study.

Device: Compliance monitoring with electronic device

Interventions

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.

Electronic compliance monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 16, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

FI (1)