SNIIRAM DatabaseSANTENCT04211077
Suicidal Risk Factors Associated With Opioid Analgesics Use
An observational study of SNIIRAM Database, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SNIIRAM Database
- What is being tested?
- Date collection
- How many people
- 273,221 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: having received at least one reimbursed delivery of an opioid analgesic (morphine, oxycodone, fentanyl, tramadol, codeine, or lamaline) but who have never received a refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).
Who may be able to join
- 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).
Who cannot join
- refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suicidal Risk Factors Associated With Opioid Analgesics Use : a Pharmacoepidemiological Study
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.
Read more
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
Read the 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:
- 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
- Conditions
- SNIIRAM Database
- Being tested
- Date collection
- Keywords
- Suicide attempt, Analgesics, Opioid, pharmacoepiemiology
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date collectionOther
Data collection from national SNIIRAM and PMSI database
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Occurrence of a SA according to PMSI Receives: Other: Date collection | |
| Group 2 | Occurrence of accidental opioid analgesics overdose according to PMSI code Receives: Other: Date collection | |
| Group 3 | Controls : Absence of SA and accidental opioid analgesics overdose Receives: Other: Date collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Risk Factors Associated with Opioid Analgesics Use
Occurrence of a suicide attempt
Measured: 1 year
Secondary outcomes (7)
Socio-demographic characteristics (potential risk factor)
age, gender, socioeconomical status
Measured: 1 year
Other analgesic use (potential risk factor)
Prescription of opioid and non-opioid analgesics (name, duration of prescription, average daily dose)
Measured: 1 year
Psychotropic use (potential risk factor)
Prescription psychotropic drugs (name, duration of prescription, average daily dose)
Measured: 1 year
Comorbidities (potential risk factor)
Presence of somatic and psychiatric comorbidities
Measured: 1 year
Care consumption (potential risk factor)
number, frequency and duration of hospitalizations, number and frequency of consultations (general practitioner, psychiatrist)
Measured: 1 year
Nomadism indicator (potential risk factor)
nomadism indicator (proportion of drugs obtained with overlapping prescriptions and from different doctors over all reimbursed quantities)
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Jan 2020
- Primary completion1 Dec 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SNIIRAM DatabaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 273,221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)
- Responsible party
- Sponsor
- Investigators
- Emile OLIE, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211077
- Sponsor's protocol ID
- RECHMPL18_0428
- Acronym
- SANTE
- Status last verified
- Sep 2021
- First submitted
- 18 Dec 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Nobile B, Nogue E, Picot MC, Courtet P, Chenaf C, Authier N, Olie E. Association Between Opioid Analgesics and Suicide Attempts: A Nationwide French Case-Crossover Study. CNS Drugs. 2025 Dec;39(12):1331-1340. doi: 10.1007/s40263-025-01221-4. Epub 2025 Aug 30.
PubMed 40884605
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicidal Risk Factors Associated With Opioid Analgesics Use : a Pharmacoepidemiological Study
- ClinicalTrials.gov ID
- NCT04211077
- Acronym / sponsor ID
- SANTE / RECHMPL18_0428
- Conditions
- SNIIRAM Database
- Keywords
- Suicide attempt, Analgesics, Opioid, pharmacoepiemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273,221 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- CHU Clermont Ferrand - Dpt Pharmacologie Médicale (Pr Nicolas AUTHIER)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Date collectionOccurrence of a SA according to PMSI |
| Group 2 | – | Other: Date collectionOccurrence of accidental opioid analgesics overdose according to PMSI code |
| Group 3 | – | Other: Date collectionControls : Absence of SA and accidental opioid analgesics overdose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- having received at least one reimbursed delivery of an opioid analgesic (morphine, oxycodone, fentanyl, tramadol, codeine, or lamaline) but who have never received a refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- refund of methadone or buprenorphine over the period 2012-2017 (SNIIRAM database).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date collectionData collection from national SNIIRAM and PMSI database | Other | Group 1, Group 2, Group 3 |
Primary outcome
Suicidal Risk Factors Associated with Opioid Analgesics Use
Time frame: 1 year
Occurrence of a suicide attempt
7 secondary outcomes
Socio-demographic characteristics (potential risk factor)
Time frame: 1 year
Other analgesic use (potential risk factor)
Time frame: 1 year
Psychotropic use (potential risk factor)
Time frame: 1 year
Comorbidities (potential risk factor)
Time frame: 1 year
Care consumption (potential risk factor)
Time frame: 1 year
Nomadism indicator (potential risk factor)
Time frame: 1 year
Delay between first prescription of opioid analgesics and occurrence of suicide attempt
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 40884605Nobile B, Nogue E, Picot MC, Courtet P, Chenaf C, Authier N, Olie E. Association Between Opioid Analgesics and Suicide Attempts: A Nationwide French Case-Crossover Study. CNS Drugs. 2025 Dec;39(12):1331-1340. doi: 10.1007/s40263-025-01221-4. Epub 2025 Aug 30.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emile OLIE, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SNIIRAM Database, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Risk Factors Associated with Opioid Analgesics Use (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.