Evaluation of the Management of Tramadol Use Disorders

NCT04550754 | Completed

• 1 other identifier: RECHMPL20_0430
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Withdrawal

Keywords

Substance use disorder; Programme de Medicalisation des Systèmes d'Information; tramadol

Outcome Measures

Primary Outcomes (1)

• Medical Management of Tramadol withdrawal syndrome

  Management by substitution drugs, by therapeutic degrowth

  1 day

Secondary Outcomes (1)

• Tramadol withdrawal syndrome experienced by patients

  1 day

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults hospitalized in Montpellier University Hospital and Nîmes University Hospital for Tramadol withdrawal

You may qualify if:

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

You may not qualify if:

• \<18 years old
• History of misuse or addiction for tramadol

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hélène Peyrière, PH

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 16, 2020
• Study Start: September 17, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

FR (1)