Evaluation of the Management of Tramadol Use Disorders

Evaluation of the Medical Management of Tramadol Use Disorders in Patients Hospitalized for Tramadol Withdrawal

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04550754

Enrollment

Registered

2020-09-16

Start date

2020-09-17

Completion date

2021-06-01

Last updated

2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Withdrawal

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Medical Management of Tramadol withdrawal syndrome	1 day	Management by substitution drugs, by therapeutic degrowth

Secondary

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

Countries

France

Outcome results