Suicidal Risk Factors Associated With Opioid Analgesics Use | NCT04211077

Studies
Suicidal Risk Factors Associated With Opioid Analgesics Use

NCT04211077

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Sep 2, 2021Actual

Enrollment

273,221Actual

Phase

Not provided

Conditions

SNIIRAM Database

Interventions

Date collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 1, 2020Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Dec 18, 2019

First Submission Date that Met QC Criteria

Dec 20, 2019

First Posted Date

Dec 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 2, 2021Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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:

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)
To Evaluate the dose-effect of opioid analgesics on the risk of SA (case-control and case-crossover design).
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

273,221Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1	Occurrence of a SA according to PMSI	Other: Date collection
Group 2	Occurrence of accidental opioid analgesics overdose according to PMSI code	Other: Date collection
Group 3	Controls : Absence of SA and accidental opioid analgesics overdose	Other: Date collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Date collection	Other	Data collection from national SNIIRAM and PMSI database	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Suicidal Risk Factors Associated with Opioid Analgesics Use	Occurrence of a suicide attempt	1 year

Secondary Outcomes

Measure	Description	Time Frame
Socio-demographic characteristics (potential risk factor)	age, gender, socioeconomical status	1 year
Other analgesic use (potential risk factor)	Prescription of opioid and non-opioid analgesics (name, duration of prescription, average daily dose)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

having received at least one reimbursed delivery of an opioid analgesic (morphine, oxycodone, fentanyl, tramadol, codeine, or lamaline) but who have never received a refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emile OLIE, MD, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40884605	Derived	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 Dec;39(12):1331-1340. doi: 10.1007/s40263-025-01221-4. Epub 2025 Aug 30.

ID	Term
D013405	Suicide
D016728	Self-Injurious Behavior
D001526	Behavioral Symptoms
D001519	Behavior