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Evaluation of the Management of Tramadol Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550754
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : October 25, 2021
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
In France, In recent years, there has been a steady increase in reports of abuse and dependence on tramadol. Over 50% of tramadol withdrawal syndromes involve taking tramadol in therapeutic doses, sometimes for short periods of less than a week. Physical dependence can develop when a therapeutic maintenance dose is prescribed for the treatment of mild to moderate pain. Due to its mixed mechanism of action, tramadol withdrawal syndromes are not only characterized by classic signs of opioid withdrawal (muscle pain, mydriasis, sweating, nausea and vomiting, tearing, rhinorrhea, yawning, fever, insomnia, etc.). The properties of this substance on serotonin explain the effects which are added to the morphine-mimetic withdrawal of tramadol. Analysis of spontaneous reports shows "psychological and psychic" signs of withdrawal. Currently, there is no validated protocol for the management of tramadol withdrawal. The main objective is to assess the different options for managing tramadol withdrawal: opioid maintenance therapy and symptomatic treatments, in relation to the addictive and psychiatric co-morbidities in patients. The study also provides insight into the different types of withdrawal syndromes experienced by patients in order to raise awareness among doctors when prescribing tramadol.

Condition or disease
Withdrawal

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Medical Management of Tramadol Use Disorders in Patients Hospitalized for Tramadol Withdrawal
Actual Study Start Date : September 17, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Groups and Cohorts
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Group/Cohort
Patients hospitalized for tramadol withdrawal
Patients hospitalized for tramadol withdrawal in Montpellier University Hospital and Nîmes University Hospital from 01/01/2015 to 31/12/2019


Outcome Measures
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Primary Outcome Measures :
  1. Medical Management of Tramadol withdrawal syndrome [ Time Frame: 1 day ]
    Management by substitution drugs, by therapeutic degrowth


Secondary Outcome Measures :
  1. Tramadol withdrawal syndrome experienced by patients [ Time Frame: 1 day ]
    Description of classic cpioid withdrawal symptoms and atypical aymptoms apecific to


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults hospitalized in Montpellier University Hospital and Nîmes University Hospital for Tramadol withdrawal
Criteria

Inclusion criteria:

  • >18 years old
  • Tramadol actual misuse/addiction
  • Patients hospitalized for Tramadol withdrawal

Exclusion criteria:

  • <18 years old
  • History of misuse or addiction for tramadol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550754


Locations
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France
Uhmontpellier
Montpellier, France, 34290
Sponsors and Collaborators
University Hospital, Montpellier
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Hélène Peyrière, PH UH Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04550754    
Other Study ID Numbers: RECHMPL20_0430
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Substance use disorder
Programme de Medicalisation des Systèmes d'Information
tramadol