- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684317
Primary Dependence to Analgesic Drugs (NEO-ADDICT)
August 18, 2022 updated by: University Hospital, Toulouse
Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting
Abuse of analgesics represents an important part of prescription drug abuse.
The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context.
This issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin).
In France, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal.
Trends of growing abuse are also reported for other analgesics.
Patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse.
There is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care.
Given the extensive use of analgesic drugs in France, the problem of primary dependence should not be neglected.
Since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.
Study Overview
Status
Recruiting
Conditions
Detailed Description
To date, prescription drug abuse has been considered in terms of the secondary or tertiary prevention, and primary prevention remains poorly explored.
By reconstructing the entire trajectories of patients having developed primary drug dependence, from the genesis of first drug exposures, investigators will identify patients' profiles and early changes in drug use that could accurately predict future complications.
Pharmacoepidemiological methods are particularly relevant in the field of abuse and drug dependence.
By definition, specialized care seeking can only be achieved after emergence and identification of the problem.
Outpatients data obtained through medico-administrative database are then the only source of evidence that could enable to ascertain accurately history of past drug consumption
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maryse Lapeyre-Mestre, MD
- Phone Number: 33-561145606
- Email: maryse.lapeyre-mestre@univ-tlse3.fr;
Study Locations
-
-
-
Toulouse, France
- Recruiting
- University Hospital Toulouse
-
Contact:
- Maryse Lapeyre-Mestre, MD PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects included in the SNIIRAM database (affiliated to the 3 French main Insurance Scheme)
Description
Inclusion Criteria:
- Subjects included in the SNIIRAM (French National inter-scheme health insurance information system) database
- Age >18 at index date (date of first analgesic dispensing)
- At least three dispensing of analgesic drugs
- At least two years of available follow-up at the date of first analgesic dispensing in the SNIIRAM database
- No dispensing for any of the analgesics of interest in the past 12 months (selection of new users only)
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of complications in relation with primary drug dependence
Time Frame: 12 months
|
occurrence of complications in relation with primary drug dependence (hospitalization for complications related to analgesic use, long term condition or initiation of drug for opioid dependence)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of analgesic drug dependence
Time Frame: 12 months
|
To estimate incidence of analgesic drug dependence in the French general population using the national SNIIRAM database
|
12 months
|
Drug consumption in patients with primary dependence to analgesics
Time Frame: 12 months
|
Change in duration of treatment between baseline and M12
|
12 months
|
Drug consumption in patients with primary dependence to analgesics
Time Frame: 12 months
|
Change in dose between baseline and M12
|
12 months
|
Drug consumption in patients with primary dependence to analgesics
Time Frame: 12 months
|
Change in number of drugs between baseline and M12
|
12 months
|
Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences
Time Frame: 12 months
|
Drug misuse (dose and/or duration superior to recommendations)
|
12 months
|
Dependance
Time Frame: up to 12 months
|
Doctor shopping behaviour (multiple different prescribers for the same drugs)
|
up to 12 months
|
Initiation of a drug for opioid dependence
Time Frame: up to 12 months
|
up to 12 months
|
|
Mortality
Time Frame: up to 12 months
|
Number of deaths between baseline and M12
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maryse Lapeyre-Mestre, MD PhD, University Hosptial toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
July 18, 2018
First Submitted That Met QC Criteria
September 24, 2018
First Posted (Actual)
September 25, 2018
Study Record Updates
Last Update Posted (Actual)
August 19, 2022
Last Update Submitted That Met QC Criteria
August 18, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/16/8914
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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