Suicidal Risk Factors Associated With Opioid Analgesics Use

Completed

• Conditions: SNIIRAM Database
• Interventions: Other: Date collection

• Registration Number: NCT04211077
• Lead Sponsor: University Hospital, Montpellier

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:

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

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-26
• Study Start: 2020-01-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273221

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Suicidal Risk Factors Associated with Opioid Analgesics Use	1 year	Occurrence of a suicide attempt

Secondary Outcome Measures

Name	Time	Method
Socio-demographic characteristics (potential risk factor)	1 year	age, gender, socioeconomical status
Psychotropic use (potential risk factor)	1 year	Prescription psychotropic drugs (name, duration of prescription, average daily dose)
Comorbidities (potential risk factor)	1 year	Presence of somatic and psychiatric comorbidities
Nomadism indicator (potential risk factor)	1 year	nomadism indicator (proportion of drugs obtained with overlapping prescriptions and from different doctors over all reimbursed quantities)
Delay between first prescription of opioid analgesics and occurrence of suicide attempt	1 year	delay between first prescription of opioid analgesics and occurrence of suicide attempt
Care consumption (potential risk factor)	1 year	number, frequency and duration of hospitalizations, number and frequency of consultations (general practitioner, psychiatrist)
Other analgesic use (potential risk factor)	1 year	Prescription of opioid and non-opioid analgesics (name, duration of prescription, average daily dose)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France