Clinical trial NCT04211077: Suicidal Risk Factors Associated With Opioid Analgesics Use
Official title: Suicidal Risk Factors Associated With Opioid Analgesics Use : a Pharmacoepidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SNIIRAM Database
Keywords: Suicide attempt
Analgesics
Opioid
pharmacoepiemiology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)
First posted: 2019-12-26
Enrollment: 273221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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).

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

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).

Primary outcomes:
measure: Suicidal Risk Factors Associated with Opioid Analgesics Use
timeFrame: 1 year
Secondary outcomes:
measure: Socio-demographic characteristics (potential risk factor)
timeFrame: 1 year
measure: Other analgesic use (potential risk factor)
timeFrame: 1 year
measure: Psychotropic use (potential risk factor)
timeFrame: 1 year
measure: Comorbidities (potential risk factor)
timeFrame: 1 year
measure: Care consumption (potential risk factor)
timeFrame: 1 year
measure: Nomadism indicator (potential risk factor)
timeFrame: 1 year
measure: Delay between first prescription of opioid analgesics and occurrence of suicide attempt
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Emile OLIE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: