Suicidal Risk Factors Associated With Opioid Analgesics Use

NCT ID: NCT04211077

Last Updated: 2021-09-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

273221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-06-01

Brief Summary

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There is an increase in prescriptions for analgesics opioids and overdose mortality in France.

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

Detailed Description

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Main objective:

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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SNIIRAM Database

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Occurrence of a SA according to PMSI

Date collection

Intervention Type OTHER

Data collection from national SNIIRAM and PMSI database

Group 2

Occurrence of accidental opioid analgesics overdose according to PMSI code

Date collection

Intervention Type OTHER

Data collection from national SNIIRAM and PMSI database

Group 3

Controls : Absence of SA and accidental opioid analgesics overdose

Date collection

Intervention Type OTHER

Data collection from national SNIIRAM and PMSI database

Interventions

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Date collection

Data collection from national SNIIRAM and PMSI database

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adults \>18 years
* 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

\- refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emile OLIE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 40884605 (View on PubMed)

Other Identifiers

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RECHMPL18_0428

Identifier Type: -

Identifier Source: org_study_id

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