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Suicidal Risk Factors Associated With Opioid Analgesics Use (SANTE)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

SNIIRAM Database

Treatments

Other: Date collection

Study type

Observational

Funder types

Other

Identifiers

NCT04211077
RECHMPL18_0428

Details and patient eligibility

About

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

Full 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

Enrollment

273,221 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

273,221 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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