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Completed

NCT Number: NCT04211077

Suicidal Risk Factors Associated With Opioid Analgesics Use

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

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Key information

Conditions

SNIIRAM Database Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide, Attempted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Date collection

Other

Data collection from national SNIIRAM and PMSI database

Primary outcomes

  1. Suicidal Risk Factors Associated with Opioid Analgesics Use

    Time frame: 1 year

    Occurrence of a suicide attempt

Secondary outcomes

  1. Socio-demographic characteristics (potential risk factor)

    Time frame: 1 year

    age, gender, socioeconomical status

  2. Other analgesic use (potential risk factor)

    Time frame: 1 year

    Prescription of opioid and non-opioid analgesics (name, duration of prescription, average daily dose)

  3. Psychotropic use (potential risk factor)

    Time frame: 1 year

    Prescription psychotropic drugs (name, duration of prescription, average daily dose)

  4. Comorbidities (potential risk factor)

    Time frame: 1 year

    Presence of somatic and psychiatric comorbidities

  5. Care consumption (potential risk factor)

    Time frame: 1 year

    number, frequency and duration of hospitalizations, number and frequency of consultations (general practitioner, psychiatrist)

  6. Nomadism indicator (potential risk factor)

    Time frame: 1 year

    nomadism indicator (proportion of drugs obtained with overlapping prescriptions and from different doctors over all reimbursed quantities)

  7. Delay between first prescription of opioid analgesics and occurrence of suicide attempt

    Time frame: 1 year

    delay between first prescription of opioid analgesics and occurrence of suicide attempt

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)

Registry information

Official study title

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

Acronym: SANTE

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 26, 2019
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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