Suicidal Risk Factors Associated With Opioid Analgesics Use (SANTE)

Suicidal Risk Factors Associated With Opioid Analgesics Use : a Pharmacoepidemiological Study

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

Study Overview

• Status: Completed
• Conditions: SNIIRAM Database
• Intervention / Treatment: Other: Date collection

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 Type: Observational
• Enrollment (Actual): 273221

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

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

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).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Occurrence of a SA according to PMSI	Other: Date collection; Data collection from national SNIIRAM and PMSI database
Group 2; Occurrence of accidental opioid analgesics overdose according to PMSI code	Other: Date collection; Data collection from national SNIIRAM and PMSI database
Group 3; Controls : Absence of SA and accidental opioid analgesics overdose	Other: Date collection; Data collection from national SNIIRAM and PMSI database

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	1 year
Psychotropic use (potential risk factor)	Prescription psychotropic drugs (name, duration of prescription, average daily dose)	1 year
Comorbidities (potential risk factor)	Presence of somatic and psychiatric comorbidities	1 year
Care consumption (potential risk factor)	number, frequency and duration of hospitalizations, number and frequency of consultations (general practitioner, psychiatrist)	1 year
Nomadism indicator (potential risk factor)	nomadism indicator (proportion of drugs obtained with overlapping prescriptions and from different doctors over all reimbursed quantities)	1 year
Delay between first prescription of opioid analgesics and occurrence of suicide attempt	delay between first prescription of opioid analgesics and occurrence of suicide attempt	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (ACTUAL): December 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Opioid; Analgesics; Suicide attempt; pharmacoepiemiology
• Other Study ID Numbers: RECHMPL18_0428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No