Suicide Attempts and Tramadol : a Case Report

Repeated Suicide Attempts in a Patient Suffering From Addiction to Tramadol: a Case Report

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.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted; Addiction

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

• Multiple suicide attempts
• Tramadol addiction

NA : patient case report

Exclusion criteria:

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptomatology	Depressive symptomatology assessed with the Montgomery Asberg Depression Rating Scale (MADRS). The total score ranges from 0 to 60 : scores between 0 and 6 : no depression,; scores between 7 and 19 : mild depression,; scores between 20 and 34 : moderate depression; scores above 34 : severe depression	day 1
Suicidal ideation	Suicidal thoughts assessed with the Columbia Suicide Severity Scale (C-SSRS). The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.	day 1
Psychological pain	Psychological pain assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree	day 1
Anxiety	Anxiety level assessed with a Likert scale : Strongly disagree, Disagree, Neutral, Agree, Strongly agree	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Bénédicte NOBILE, PharmD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Suicide; Addiction; Opioids
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Compulsive Behavior; Impulsive Behavior; Suicide; Suicide, Attempted; Behavior, Addictive
• Other Study ID Numbers: RECHMPL21_0571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No