Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The specific complication of alcoholism in the Intesive care is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complication is agitation. The Baclorea Randomized controlled Study showed that Baclofen significantly reduced the incidence of agitation in ICU but increased the length of stay in ICU. The BACLO-PTSD Study aims at assessing whether Baclofen administered during ICU stay to reduce the incidence of agitation could also reduce the incidence of Post-Traumatic Stress Disorder (PTSD) in mean term compared to placebo Methods/Design: This prospective, randomized, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients included in the BACLO-REA Trial will have to respond to standardized questionnaires to detect Post-Traumatic Stress Disorder (Primary outcome) and to assess quality of life (Secondary outcome). Discussion: Patients will be assessed blind to the randomization group. If patients in the Baclofen group present have a lower incidence of PTSD, the study will suggest that the increase in the length of ICU stay in the baclofen group could be beneficial to reduce the incidence of PTSD in patients with alcohol intake above de NIAAA recommendations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05877807
Study type	Observational
Source	Nantes University Hospital
Contact	Mickael VOURC'H, PH
Phone	02.44.76.80.53
Email	mickael.vourch@chu-nantes.fr
Status	Recruiting
Phase
Start date	September 3, 2023
Completion date	September 3, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Baclofen to Prevent Post-Traumatic Stress Disorder — BACLO-PTSD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms