Suicidal Risk Factors Associated With Opioid Analgesics Use

Study Overview
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Brief Summary
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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
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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

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

Conditions
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SNIIRAM Database

Intervention / Treatment
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* Other: Date collection


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Occurrence of a SA according to PMSI | Other: Date collection<br>* Data collection from national SNIIRAM and PMSI database<br>|
| Group 2<br>Occurrence of accidental opioid analgesics overdose according to PMSI code | Other: Date collection<br>* Data collection from national SNIIRAM and PMSI database<br>|
| Group 3<br>Controls : Absence of SA and accidental opioid analgesics overdose | Other: Date collection<br>* Data collection from national SNIIRAM and PMSI database<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Suicide attempt, Analgesics, pharmacoepiemiology