Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

NCT05877807 | Completed

• 1 other identifier: RC21_0251
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 13

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.

Conditions

Alcoholism; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)

  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.

  5 years post hospitalization

Secondary Outcomes (5)

• Evaluation of the quality of life using the questionnaire European Quality of Life-5 Dimensions (EQ-5D)

  5 years post hospitalization

• Health assessement with the Short Form (SF-36 Quiz)

  5 years post hospitalization

• Screen for anxiety and depressive disorders with Hospital Anxiety and Depression scale (HAD Quiz)

  5 years post hospitalization

• Evaluation of the Posttraumatic stress disorder (PCL-S Quiz)

  5 years post hospitalization

• Assessment of patient Habits

  5 years post hospitalization

Study Arms (2)

Experimental : BACLOFEN

Patient will receive baclofen caps

Drug: Baclofen

Placebo Comparator : PLACEBO

Patient will receive placebo caps (lactose)

Other: Placebo

Interventions

Baclofen DRUG

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.

Experimental : BACLOFEN

Placebo OTHER

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.

Placebo Comparator : PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who took part in the Baclorea study between 2016 and 2019. This study assessed the benefit of treatment with baclofen for the prevention of agitation in intensive care during the period of mechanical ventilation.

You may qualify if:

• All incident patients included in the BACLOREA trial. As a reminder, the criteria were :
• Consumption of alcohol qualified as "at risk" (For men aged 18 to 64: Consumption ≥ 14 drinks/week in the month preceding hospitalization; For men \> 65 and women: Consumption \> 7 drinks /week in the month preceding hospitalization).
• AND Intubated, ventilated with an expected duration of mechanical ventilation of at least 48 hours;
• AND Aged 18 to 80

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (13)

Brest University Hospital

Brest, Finistère, 29200, France

Location

Cornouaille Hospital

Quimper, Finistère, 29000, France

Location

Montpellier University Hospital

Montpellier, Hérault, 34000, France

Location

Rennes University Hospital

Rennes, Ile-et-Vilaine, 35000, France

Location

Tours University Hospital

Tours, Indre-et-Loire, 37000, France

Location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Saint-Nazaire Hospital

Saint-Nazaire, Loire-Atlantique, 44600, France

Location

Angers University Hospital

Angers, Maine-et-Loire, 49000, France

Location

South Bretagne Hospital Center

Lorient, Morbihan, 56100, France

Location

Le Mans University Hospital

Le Mans, Sarthe, 72000, France

Location

Vendee Departmental Hospital

La Roche-sur-Yon, Vendee, 85000, France

Location

Poitiers University Hospital

Poitiers, Vienne, 86000, France

Location

Saint-Antoine Hospital (AP-HP)

Paris, Île-de-France Region, 75012, France

Location

Related Publications (1)

• Bouras M, Asehnoune K, Robert-Valli Y, Mahe PJ, Reignier J, Maamar A, Lacherade JC, Jonas M, Jung B, Ferrandiere M, Jaber S, Flet L, Moriconi M, Lasocki S, Smonig R, Guitton C, Ehrmann S, Rozec B, Volteau C, Vourc'h M; BACLOREA study group. Effect of high-dose baclofen on post-traumatic stress disorder symptoms five years after hospitalization among critically ill patients with unhealthy alcohol use. Sci Rep. 2026 Jan 8;16(1):1088. doi: 10.1038/s41598-025-27423-w.

  PMID: 41507241 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Karim ASEHNOUNE, PU-PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 26, 2023
• Study Start: September 3, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

FR (13)