Suicidal Risk Factors Associated With Opioid Analgesics Use
NCT ID: NCT04211077
Last Updated: 2021-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
273221 participants
OBSERVATIONAL
2020-01-01
2021-06-01
Brief Summary
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In the United States, the consumption of opioid analgesics is associated with excess mortality, especially suicide. In France, the investigator team showed retrospectively a link between history of suicide attempt (SA) and use of analgesics in general elderly population.
It is important to determine if there is a link between the prescription of opioid analgesics and suicide attempts, in a longitudinal study in general population.
The originality of the project lies in:
* the absence of a French epidemiological study on the link between opioid analgesics and suicide attempt / mortality despite the context of "opioid crisis",
* taking into account the terms of consumption of care
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Detailed Description
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To estimate the relative risk (Odds ratio) of SA associated with exposure to opioid analgesics in a case-crossover design study
Secondary objectives:
1. To Compare the profile of subjects who attempted suicide versus subjects who had an accidental drug intoxication with opioids vs subjects who did not attempt suicide or did not have an accidental overdose with opioid analgesics (case-control design)
2. To Evaluate the dose-effect of opioid analgesics on the risk of SA (case-control and case-crossover design).
3. To Identify changes in care consumption (medical consultations, co-prescriptions, changes in analgesic doses) in the 3 months preceding a SA in patients who received at least one prescription for opioid analgesics in the same period.
The Database is retrospective (2012-2017) Two methods will be used
-case crossover study (reference period of 3 months preceding the SA versus 3 control periods of 3 months without SA.- Case control study (Age and gender matching) Case 1 = occurrence of a SA according to PMSI codes "X60 to X84" between the date of the first delivery of opioid analgesics recorded in the SNIIRAM database since 2012 and December 2017; Case 2 = subjects who had accidental drug intoxication with opioid analgesics according to PMSI code "T40"; Controls = absence of SA and accidental opioid overdose
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Group 1
Occurrence of a SA according to PMSI
Date collection
Data collection from national SNIIRAM and PMSI database
Group 2
Occurrence of accidental opioid analgesics overdose according to PMSI code
Date collection
Data collection from national SNIIRAM and PMSI database
Group 3
Controls : Absence of SA and accidental opioid analgesics overdose
Date collection
Data collection from national SNIIRAM and PMSI database
Interventions
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Date collection
Data collection from national SNIIRAM and PMSI database
Eligibility Criteria
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Inclusion Criteria
* having received at least one reimbursed delivery of an opioid analgesic (morphine, oxycodone, fentanyl, tramadol, codeine, or lamaline) over the period 2012-2017 (SNIIRAM database).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Emile OLIE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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Uhmontpellier
Montpellier, , France
Countries
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References
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Nobile B, Nogue E, Picot MC, Courtet P, Chenaf C, Authier N, Olie E. Association Between Opioid Analgesics and Suicide Attempts: A Nationwide French Case-Crossover Study. CNS Drugs. 2025 Aug 30. doi: 10.1007/s40263-025-01221-4. Online ahead of print.
Other Identifiers
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RECHMPL18_0428
Identifier Type: -
Identifier Source: org_study_id
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