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Suicidal Risk Factors Associated With Opioid Analgesics Use

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04211077
Acronym
SANTE
Enrollment
273221
Registered
2019-12-26
Start date
2020-01-01
Completion date
2021-06-01
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SNIIRAM Database

Keywords

Suicide attempt, Analgesics, Opioid, pharmacoepiemiology

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

Interventions

Data collection from national SNIIRAM and PMSI database

Sponsors

CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Suicidal Risk Factors Associated with Opioid Analgesics Use1 yearOccurrence of a suicide attempt

Secondary

MeasureTime frameDescription
Socio-demographic characteristics (potential risk factor)1 yearage, gender, socioeconomical status
Other analgesic use (potential risk factor)1 yearPrescription of opioid and non-opioid analgesics (name, duration of prescription, average daily dose)
Psychotropic use (potential risk factor)1 yearPrescription psychotropic drugs (name, duration of prescription, average daily dose)
Comorbidities (potential risk factor)1 yearPresence of somatic and psychiatric comorbidities
Care consumption (potential risk factor)1 yearnumber, frequency and duration of hospitalizations, number and frequency of consultations (general practitioner, psychiatrist)
Nomadism indicator (potential risk factor)1 yearnomadism 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 attempt1 yeardelay between first prescription of opioid analgesics and occurrence of suicide attempt

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026