NCT05075291

Brief Summary

In France, over the last years the use weak opioid analgesics decreased́, whereas that of strong opioid analgesics (OFMA). Hospitalizations for opioid overdose increased́ by 128% from 2000 to 2015, and deaths related to prescribed opioid overdose increased significantly, by 161%, from 2000 to 2014.In addition, recent studies suggest a link between opioid system dysfunction and suicidal behavior. In parallel, studies are emerging showing the potential interest of using Tramadol as an antidepressant. Indeed, this opiate analgesic also acts on the serotonergic and dopaminergic systems, and would have an antidepressant effect.Thus, the investigators can legitimately wonder whether the use of Tramadol as an antidepressant might not pose a problem in patients at risk of suicide. This study aims to describe a clinical case of a patient hospitalized in the Department of Psychiatric Emergency and Post-Emergency (Montpellier University Hospital) who developed a severe addiction to Tramadol (consumption up to 5 times the maximum recommended dose per day) and evaluate whether this may have increased her suicidal risk, in order to warn prescribers about the suicidal risk of Tramadol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
Last Updated

October 12, 2021

Status Verified

September 1, 2021

Enrollment Period

Same day

First QC Date

September 18, 2021

Last Update Submit

September 29, 2021

Conditions

Keywords

SuicideAddictionOpioids

Outcome Measures

Primary Outcomes (1)

  • Lifetime suicidal events

    Occurrence of suicidal events (actuel, interrupted and aborted or self-aborted suicide attempts) based on the patient medical records.

    day 1

Secondary Outcomes (4)

  • Depressive symptomatology

    day 1

  • Suicidal ideation

    day 1

  • Psychological pain

    day 1

  • Anxiety

    day 1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A single patient with multiple suicide attempts related to her addiction to Tramadol.

You may qualify if:

  • Multiple suicide attempts
  • Tramadol addiction
  • NA : patient case report

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Suicide, AttemptedBehavior, AddictiveSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorCompulsive BehaviorImpulsive Behavior

Study Officials

  • Bénédicte NOBILE, PharmD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2021

First Posted

October 12, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2020

Study Completion

July 30, 2021

Last Updated

October 12, 2021

Record last verified: 2021-09

Locations