|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01182402 |
|
Date of registration:
|
11/08/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Electronic Compliance Monitoring in Opioid Substitution Treatment
EHSO |
|
Scientific title:
|
Electronic Compliance Monitoring in Opioid Substitution Treatment |
|
Date of first enrolment:
|
September 2010 |
|
Target sample size:
|
37 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01182402 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Opiate Dependence
|
|
Intervention(s)
|
|
Device: Compliance monitoring with electronic device
|
|
Primary Outcome(s)
|
|
The effectiveness of treatment (Treatment Outcomes Profile TOP)
[Time Frame: Every two months.]
|
|
Secondary Outcome(s)
|
|
Patients´opinions about the treatment.
[Time Frame: Once when the study phase ends (after four months).]
|
|
Secondary ID(s)
|
|
KUH5703432
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|