Opiate DependenceDEMDOUNCT03635346
Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD
An observational study of Opiate Dependence and Chronic Pain, run by University Hospital, Brest at 1 site in France.
Trial summary
prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Opiate Dependence, Chronic Pain
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2016to 10 Mar 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: analysis of SUD criteria in a population with a chronic pain (non cancer) , consulting a center specialized in pain mangement
Who may be able to join
- patient with a non cancer chronic pain
- consulting a CETD center
Who cannot join
- non understanding of french
Trial locations and contacts
1 site in 1 country.
About this study
prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain.
the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.
- Conditions
- Opiate Dependence, Chronic Pain
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM 5 criteria of SUD
11 criteria of SUD
Measured: Day 0 (at the inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start3 Jun 2016
- Primary completion3 Sep 2016
- Study completion10 Mar 2018
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.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635346
- Sponsor's protocol ID
- DEMDOU 2016.CE13
- Acronym
- DEMDOU
- Status last verified
- Jul 2018
- First submitted
- 14 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD
- ClinicalTrials.gov ID
- NCT03635346
- Acronym / sponsor ID
- DEMDOU / DEMDOU 2016.CE13
- Conditions
- Opiate Dependence, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 3 Sep 2016 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 17 Aug 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.
prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain.
the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- analysis of SUD criteria in a population with a chronic pain (non cancer) , consulting a center specialized in pain mangement
Key inclusion criteria (2 listed)
- patient with a non cancer chronic pain
- consulting a CETD center
Key exclusion criteria (1 listed)
- non understanding of french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DSM 5 criteria of SUD
Time frame: Day 0 (at the inclusion)
11 criteria of SUD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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 Opiate Dependence and Chronic Pain, run by University Hospital, Brest 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 2 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: finished, as of the sponsor's last update on 17 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DSM 5 criteria of SUD (time frame: Day 0 (at the inclusion)). 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 17 Aug 2018.