Evaluation of the Management of Tramadol Use Disorders

Completed

• Conditions: Withdrawal

• Registration Number: NCT04550754
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-16
• Study Start: 2020-09-17
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medical Management of Tramadol withdrawal syndrome	1 day	Management by substitution drugs, by therapeutic degrowth

Secondary Outcome Measures

Name	Time	Method
Tramadol withdrawal syndrome experienced by patients	1 day	Description of classic cpioid withdrawal symptoms and atypical aymptoms apecific to

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France