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Evaluation of the Management of Tramadol Use Disorders

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Withdrawal

Study type

Observational

Funder types

Other

Identifiers

NCT04550754
RECHMPL20_0430

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients hospitalized for tramadol withdrawal
Description:
Patients hospitalized for tramadol withdrawal in Montpellier University Hospital and Nîmes University Hospital from 01/01/2015 to 31/12/2019

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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