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Compliance Monitoring in Real Time During Opioid Substitution Treatment

Compliance Monitoring in Real Time During Opioid Substitution Treatment

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01183130
Enrollment
0
Registered
2010-08-17
Start date
2011-08-31
Completion date
2012-04-30
Last updated
2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Dependence

Keywords

opiate dependence, compliance monitoring, substitution treatment

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.

Interventions

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.

Sponsors

Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Opiate dependence * Suboxone treatment * Stable substitution medication dose

Exclusion criteria

* Chaotic situation in life

Design outcomes

Primary

MeasureTime frameDescription
The effectiveness of treatment (Treatment Outcomes Profile TOP)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

MeasureTime frameDescription
Patients´opinions about the treatment.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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026