Withdrawal Clinical Trial
Official title:
Evaluation of the Medical Management of Tramadol Use Disorders in Patients Hospitalized for Tramadol Withdrawal
| Verified date | October 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 1, 2021 |
| Est. primary completion date | December 1, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier | Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Medical Management of Tramadol withdrawal syndrome | Management by substitution drugs, by therapeutic degrowth | 1 day | |
| Secondary | Tramadol withdrawal syndrome experienced by patients | Description of classic cpioid withdrawal symptoms and atypical aymptoms apecific to | 1 day |
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