Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

CompletedOBSERVATIONAL
Enrollment

94

Participants

Timeline

Start Date

September 3, 2023

Primary Completion Date

February 28, 2024

Study Completion Date

February 28, 2024

Conditions
AlcoholismPost 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.

Trial Locations (13)

29000

Cornouaille Hospital, Quimper

29200

Brest University Hospital, Brest

34000

Montpellier University Hospital, Montpellier

35000

Rennes University Hospital, Rennes

37000

Tours University Hospital, Tours

44093

Nantes University Hospital, Nantes

44600

Saint-Nazaire Hospital, Saint-Nazaire

49000

Angers University Hospital, Angers

56100

South Bretagne Hospital Center, Lorient

72000

Le Mans University Hospital, Le Mans

75012

Saint-Antoine Hospital (AP-HP), Paris

85000

Vendee Departmental Hospital, La Roche-sur-Yon

86000

Poitiers University Hospital, Poitiers

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder | Biotech Hunter | Biotech Hunter