Opiate DependenceNCT01183130
Compliance Monitoring in Real Time During Opioid Substitution Treatment
A study testing Compliance monitoring with electronic device in people with Opiate Dependence, run by Kuopio University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Compliance monitoring with electronic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Opiate dependence
- Suboxone treatment
- Stable substitution medication dose
Who cannot join
- Chaotic situation in life
About this study
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.
- Conditions
- Opiate Dependence
- Being tested
- Compliance monitoring with electronic device
- Keywords
- opiate dependence, compliance monitoring, substitution treatment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance monitoring with electronic deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Compliance monitoring in real time | Experimental | 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. Receives: Device: Compliance monitoring with electronic device |
| Compliance monitoring | Active comparator | 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. Receives: Device: Compliance monitoring with electronic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of treatment (Treatment Outcomes Profile TOP)
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.
Measured: Every four weeks.
Secondary outcomes (1)
Patients´opinions about the treatment.
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.
Measured: Once when the study phase ends (after the 8 th study week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: The technology planned to be used in the study got outdated and therefore the study will not be conducted according to the initial protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich Tacke, MD, PhD, Study director, Kuopio University Hospital, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183130
- Sponsor's protocol ID
- KUH5703434
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2010
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance Monitoring in Real Time During Opioid Substitution Treatment
- ClinicalTrials.gov ID
- NCT01183130
- Acronym / sponsor ID
- KUH5703434
- Conditions
- Opiate Dependence
- Keywords
- opiate dependence, compliance monitoring, substitution treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The technology planned to be used in the study got outdated and therefore the study will not be conducted according to the initial protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliance monitoring in real time | Experimental | Device: Compliance monitoring with electronic devicePatients 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. |
| Compliance monitoring | Active comparator | Device: Compliance monitoring with electronic devicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Opiate dependence
- Suboxone treatment
- Stable substitution medication dose
Key exclusion criteria (1 listed)
- Chaotic situation in life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compliance monitoring with electronic deviceElectronic 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. | Device | Compliance monitoring, Compliance monitoring in real time |
Primary outcome
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Time frame: 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.
1 secondary outcome
Patients´opinions about the treatment.
Time frame: Once when the study phase ends (after the 8 th study week).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Tacke, MD, PhD study director
Kuopio University Hospital, University of Eastern Finland
Questions about this trial
What is this clinical trial studying?
A study testing Compliance monitoring with electronic device in people with Opiate Dependence, run by Kuopio University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of treatment (Treatment Outcomes Profile TOP) (time frame: Every four weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.