Analgesics Grade 2's AddictionNCT03297853
Prevalence, Management and Follow-up of Patients With Addiction to Opioid Analgesics
An observational study of Analgesics Grade 2's Addiction, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesics Grade 2's Addiction
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 30 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients attending addictology or hospitalization in Montpellier or Nîmes for an addiction to analgesics grade 2 between the 1st ofJanuary 2014 and the 22th of january 2017
Who may be able to join
- Requests for management for weaning or reduction of doses
- Take opioid analgesics in the absence of pain or as part of chronic non-cancer pain
- Opioid analgesics to prevent withdrawal syndrome or hyperalgesia
- Chronic consumption at inadequate dosages compared to the functional complaint evaluated by the MPR / Algologie services
- Patients over 18 years and who agree with the study
Who cannot join
- language barrier
- severe cognitive and / or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2.
Risk factors of misuse as well as diagnostic tools were identified.
Read the detailed description
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2.
Risk factors of misuse as well as diagnostic tools were identified. The objectives of our research are to determine the characteristics of the individuals suffering from an addiction to analgesics of level 2 followed in consultation of addictology in the hospital of Montpellier and Nimes and to describe the type of follow-up proposed to the patients in these two centers. It is a retrospective and descriptive study.
As part of this research, we will solicit all the patients followed in consultation of addictology or in hospitalization to the hospital of Montpellier or Nîmes for an addiction to the analgesics of grade 2 between the 1st of January 2014 and the 10th of July 2017 with requests of management for withdrawal or reduction of doses, opioid analgesics in the absence of pain or in chronic non-cancer pain, opioid analgesics to avoid withdrawal syndrome or hyperalgesia and consumptions chronic to dosages inadequate to the functional complaint evaluated by the rhumatology or algology services.
The data are collected in the medical file at the two participating institutions (Montpellier and Nîmes) and if necessary, patients not seen in consultation for more than 6 months will be recontacted.
- Conditions
- Analgesics Grade 2's Addiction
- Keywords
- Descriptive, Support, Retrospective, survey
What is being measured
The primary outcome is the main question the study is designed to answer.
50/5000 Prevalence of demand for care in addictology
Prevalence of demand for addictive care in subjects with addiction to analgesics in level 2
Measured: 1 day
Secondary outcomes (4)
Types of support proposed
Types of support proposed
Measured: 1 day
Assessment of analgesic dependence
Assessment of analgesic dependence
Measured: 1 day
History of analgesic use
History of analgesic use
Measured: 1 day
quality of life
quality of life
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jan 2014
- Primary completion31 Jul 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics Grade 2's AddictionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TARUFFI Floriane, Doctor, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297853
- Sponsor's protocol ID
- RECHMPL17_0305
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Management and Follow-up of Patients With Addiction to Opioid Analgesics
- ClinicalTrials.gov ID
- NCT03297853
- Acronym / sponsor ID
- RECHMPL17_0305
- Conditions
- Analgesics Grade 2's Addiction
- Keywords
- Descriptive, Support, Retrospective, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 29 Sep 2017 (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.
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2.
Risk factors of misuse as well as diagnostic tools were identified.
Detailed description
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2.
Risk factors of misuse as well as diagnostic tools were identified. The objectives of our research are to determine the characteristics of the individuals suffering from an addiction to analgesics of level 2 followed in consultation of addictology in the hospital of Montpellier and Nimes and to describe the type of follow-up proposed to the patients in these two centers. It is a retrospective and descriptive study.
As part of this research, we will solicit all the patients followed in consultation of addictology or in hospitalization to the hospital of Montpellier or Nîmes for an addiction to the analgesics of grade 2 between the 1st of January 2014 and the 10th of July 2017 with requests of management for withdrawal or reduction of doses, opioid analgesics in the absence of pain or in chronic non-cancer pain, opioid analgesics to avoid withdrawal syndrome or hyperalgesia and consumptions chronic to dosages inadequate to the functional complaint evaluated by the rhumatology or algology services.
The data are collected in the medical file at the two participating institutions (Montpellier and Nîmes) and if necessary, patients not seen in consultation for more than 6 months will be recontacted.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients attending addictology or hospitalization in Montpellier or Nîmes for an addiction to analgesics grade 2 between the 1st ofJanuary 2014 and the 22th of january 2017
Key inclusion criteria (5 listed)
- Requests for management for weaning or reduction of doses
- Take opioid analgesics in the absence of pain or as part of chronic non-cancer pain
- Opioid analgesics to prevent withdrawal syndrome or hyperalgesia
- Chronic consumption at inadequate dosages compared to the functional complaint evaluated by the MPR / Algologie services
- Patients over 18 years and who agree with the study
Key exclusion criteria (2 listed)
- language barrier
- severe cognitive and / or psychiatric disorders
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
50/5000 Prevalence of demand for care in addictology
Time frame: 1 day
Prevalence of demand for addictive care in subjects with addiction to analgesics in level 2
4 secondary outcomes
Types of support proposed
Time frame: 1 day
Assessment of analgesic dependence
Time frame: 1 day
History of analgesic use
Time frame: 1 day
quality of life
Time frame: 1 day
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 7 May 2018.
- Individual participant dataSharing planned: Undecided. NC
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.
TARUFFI Floriane, Doctor principal investigator
University Hospital, Montpellier
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 Analgesics Grade 2's Addiction, run by University Hospital, Montpellier 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 5 inclusion and 2 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 7 May 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?
50/5000 Prevalence of demand for care in addictology (time frame: 1 day). 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 7 May 2018.