Opioid Substitution TreatmentMSOSuiStabNCT03390829
Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)
An observational study of Opioid Substitution Treatment, run by University Hospital, Angers at 1 site in France.
Trial summary
Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional. It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Substitution Treatment
- What is being tested?
- semi-directed interviews
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2017to 20 Apr 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients receiving opiate substitution treatments considered stabilized by their GPs
Who may be able to join
- major people patients receiving opiate substitution treatments
Who cannot join
- considered unstabilized with opiate substitution treatments
Trial locations and contacts
1 site in 1 country.
About this study
Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional.
It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Centered on problems of attachment, of framework, of trust. The implementation of the opiate substitution treatments and the lifting of the product dependence appears only as a preliminary to the background work with the patient ex-user of opiate.
Read more
Finally, the literature provides little information on the experience of general practitioners and their patients under opiate substitution treatments regarding follow-up consultations in the stability phase.
The objective of this work is therefore to study the feelings on follow-up consultations, general practitioners and their patients under opiate substitution treatments considered stabilized.
- Conditions
- Opioid Substitution Treatment
- Being tested
- semi-directed interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-directed interviewsOther
semi-directed interviews
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: semi-directed interviews | |
| Doctors | Not described Receives: Other: semi-directed interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of feelings on follow-up consultations with standardized questionnaire
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start20 Oct 2017
- Primary completion20 Apr 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Substitution TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390829
- Sponsor's protocol ID
- 2017-A01752-51
- Acronym
- MSOSuiStab
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)
- ClinicalTrials.gov ID
- NCT03390829
- Acronym / sponsor ID
- MSOSuiStab / 2017-A01752-51
- Conditions
- Opioid Substitution Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 4 Jan 2018 (actual)
- 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.
Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional.
It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Centered on problems of attachment, of framework, of trust. The implementation of the opiate substitution treatments and the lifting of the product dependence appears only as a preliminary to the background work with the patient ex-user of opiate.
Finally, the literature provides little information on the experience of general practitioners and their patients under opiate substitution treatments regarding follow-up consultations in the stability phase.
The objective of this work is therefore to study the feelings on follow-up consultations, general practitioners and their patients under opiate substitution treatments considered stabilized.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: semi-directed interviews |
| Doctors | – | Other: semi-directed interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving opiate substitution treatments considered stabilized by their GPs
Key inclusion criteria (1 listed)
- major people patients receiving opiate substitution treatments
Key exclusion criteria (1 listed)
- considered unstabilized with opiate substitution treatments
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 |
|---|---|---|
| semi-directed interviewssemi-directed interviews | Other | Doctors, Patients |
Primary outcome
assessment of feelings on follow-up consultations with standardized questionnaire
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Substitution Treatment, run by University Hospital, Angers at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
assessment of feelings on follow-up consultations with standardized questionnaire (time frame: 1 hour). 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 4 Jan 2018.