Suicidal Risk Factors Associated With Opioid Analgesics Use

SNIIRAM Database Clinical Trial

— SANTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211077
• Other study ID #: RECHMPL18_0428
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273221
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• SNIIRAM Database

Intervention

Other:
• Date collection
Data collection from national SNIIRAM and PMSI database

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Risk Factors Associated with Opioid Analgesics Use	Occurrence of a suicide attempt	1 year
Secondary	Socio-demographic characteristics (potential risk factor)	age, gender, socioeconomical status	1 year
Secondary	Other analgesic use (potential risk factor)	Prescription of opioid and non-opioid analgesics (name, duration of prescription, average daily dose)	1 year
Secondary	Psychotropic use (potential risk factor)	Prescription psychotropic drugs (name, duration of prescription, average daily dose)	1 year
Secondary	Comorbidities (potential risk factor)	Presence of somatic and psychiatric comorbidities	1 year
Secondary	Care consumption (potential risk factor)	number, frequency and duration of hospitalizations, number and frequency of consultations (general practitioner, psychiatrist)	1 year
Secondary	Nomadism indicator (potential risk factor)	nomadism indicator (proportion of drugs obtained with overlapping prescriptions and from different doctors over all reimbursed quantities)	1 year
Secondary	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