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Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

NCT05877807 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2024-06-17

No results posted yet for this study

Summary

Considering the results of the Baclorea study (10% reduction in episodes of agitation in intensive care in the Baclofen group), the investigators would like to know whether this reduction in agitation also results in a reduction in the incidence of the syndrome of long-term post-traumatic stress (5 years later).

The investigators wish to contact by telephone, blinded from the randomization group as defined in the framework of the Balorea project, by telephone contact, the patients who had been included in the Balorea study between June 2016 and February 2019.

Conditions

  • Alcoholism
  • Post Traumatic Stress Disorder

Interventions

DRUG

Baclofen

Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the treatment will be administered via the nasogastric feeding tube. After extubation, the treatment will be administered either via the nasogastric tube or the oral route.

OTHER

Placebo

Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the placebo will be administered via the nasogastric feeding tube. After extubation, the placebo will be administered either via the nasogastric tube or the oral route.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Karim ASEHNOUNE, PU-PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-03
Primary Completion
2024-02-28
Completion
2024-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05877807 on ClinicalTrials.gov