Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

Completed

• Conditions: Post Traumatic Stress Disorder; Alcoholism
• Interventions: Other: Placebo; Drug: Baclofen

• Registration Number: NCT05877807
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-26
• Study Start: 2023-09-03
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo Comparator : PLACEBO	Placebo	Patient will receive placebo caps (lactose)
Experimental : BACLOFEN	Baclofen	Patient will receive baclofen caps

Primary Outcome Measures

Name	Time	Method
Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)	5 years post hospitalization	It has 2 important dimensions for the diagnosis of post-traumatic stress disorder: repetitive memories and persistent avoidance. The questionnaire is composed of 22 items to which the patient must respond using a scale of 0 to 4 (0 = not at all / 1 = a little / 2 = moderately / 3 = good-fair / 4 = extremely).; Incidence of Post traumatic stress disorder defined by a score greater or equal to 33.

Secondary Outcome Measures

Name	Time	Method
Assessment of patient Habits	5 years post hospitalization	Interrogation about Tobacco, alcohol and drug consumption (yes/no; type of drug; amount)
Evaluation of the quality of life using the questionnaire European Quality of Life-5 Dimensions (EQ-5D)	5 years post hospitalization	For each of the headings (Mobility, Autonomy, Daily Activities, Pain/Discomfort, Anxiety/Depression), the patient must indicate the statement that best describes his state of health today. 3 answers are proposed indicating the level of difficulty (1 = no difficulty / 2 = average difficulty / 3 = extreme difficulty).; The maximum value is 3 (wich is the worst outcome) and the minimum is 1 (wich is the best outcome).
Screen for anxiety and depressive disorders with Hospital Anxiety and Depression scale (HAD Quiz)	5 years post hospitalization	It has 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores to be obtained (maximum score for each score = 21 wich is the worst state).
Evaluation of the Posttraumatic stress disorder (PCL-S Quiz)	5 years post hospitalization	The scale is composed of 17 items corresponding to the 3 syndromes main causes of PTSD : Intrusion, overstimulation and avoidance.; Each question is to be scored between 1 and 5 depending on the intensity and frequency of the symptoms. The higher the total score on this 85-point scale, the worse is severe the post-traumatic stress disorder.
Health assessement with the Short Form (SF-36 Quiz)	5 years post hospitalization	This health-related quality of life scale is made up of 36 questions, divided into 8 dimensions: physical activity, life and relationships with others, physical pain, perceived general health, vitality, limitations due to mental/physical state and mental health. The patient must answer all the questions. A circling the number corresponding to the chosen answer. At the end, a score for each dimension of the SF-36 is calculated, varying from 0 to 100. A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health.

Trial Locations

Locations (13)

Montpellier University Hospital; 🇫🇷 Montpellier, Hérault, France

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France

Angers University Hospital; 🇫🇷 Angers, Maine-et-Loire, France

Brest University Hospital; 🇫🇷 Brest, Finistère, France

Cornouaille Hospital; 🇫🇷 Quimper, Finistère, France

Saint-Antoine Hospital (AP-HP); 🇫🇷 Paris, Ile-de-France, France

Rennes University Hospital; 🇫🇷 Rennes, Ile-et-Vilaine, France

Tours University Hospital; 🇫🇷 Tours, Indre-et-Loire, France

Saint-Nazaire Hospital; 🇫🇷 Saint-Nazaire, Loire-Atlantique, France

South Bretagne Hospital Center; 🇫🇷 Lorient, Morbihan, France

Le Mans University Hospital; 🇫🇷 Le Mans, Sarthe, France

Vendee Departmental Hospital; 🇫🇷 La Roche-sur-Yon, Vendee, France

Poitiers University Hospital; 🇫🇷 Poitiers, Vienne, France