AlcoholismBACLO-PTSDNCT05877807
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
An observational study of Alcoholism and Post Traumatic Stress Disorder, run by Nantes University Hospital at 13 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcoholism, Post Traumatic Stress Disorder
- What is being tested?
- Baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 13 sitesFrance
- Study dates
- 3 Sep 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All incident patients included in the BACLOREA trial. As a reminder, the criteria were :
- Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.Non-cerebrodamaged patients admitted to intensive care regardless of the causal pathology with:
- 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
Who cannot join
- Patients who died during the study or within 5 years of inclusion will not be included. Also, patients who withdrew their consent after inclusion in the Balorea study will not be included. Similarly, patients refusing to answer telephone questionnaires will not be included. Known deceased patients will not be contacted.
- Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Angers University Hospital
Angers, Maine-et-Loire, 49000
Brest University Hospital
Brest, Finistère, 29200
Vendee Departmental Hospital
La Roche-sur-Yon, Vendee, 85000
Le Mans University Hospital
Le Mans, Sarthe, 72000
South Bretagne Hospital Center
Lorient, Morbihan, 56100
Montpellier University Hospital
Montpellier, Hérault, 34000
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Saint-Antoine Hospital (AP-HP)
Paris, Île-de-France Region, 75012
Poitiers University Hospital
Poitiers, Vienne, 86000
Cornouaille Hospital
Quimper, Finistère, 29000
Rennes University Hospital
Rennes, Ile-et-Vilaine, 35000
Saint-Nazaire Hospital
Saint-Nazaire, Loire-Atlantique, 44600
Tours University Hospital
Tours, Indre-et-Loire, 37000
About this study
Official title: Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
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.
Read the 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.
- Conditions
- Alcoholism, Post Traumatic Stress Disorder
- Being tested
- Baclofen, Placebo
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : BACLOFEN | Patient will receive baclofen caps Receives: Drug: Baclofen | |
| Placebo Comparator : PLACEBO | Patient will receive placebo caps (lactose) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post hospitalization
Secondary outcomes (5)
Evaluation of the quality of life using the questionnaire European Quality of Life-5 Dimensions (EQ-5D)
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).
Measured: 5 years post hospitalization
Health assessement with the Short Form (SF-36 Quiz)
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.
Measured: 5 years post hospitalization
Screen for anxiety and depressive disorders with Hospital Anxiety and Depression scale (HAD Quiz)
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).
Measured: 5 years post hospitalization
Evaluation of the Posttraumatic stress disorder (PCL-S Quiz)
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.
Measured: 5 years post hospitalization
Assessment of patient Habits
Interrogation about Tobacco, alcohol and drug consumption (yes/no; type of drug; amount)
Measured: 5 years post hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start3 Sep 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim ASEHNOUNE, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877807
- Sponsor's protocol ID
- RC21_0251
- Acronym
- BACLO-PTSD
- Status last verified
- Jun 2024
- First submitted
- 3 Apr 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41507241
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baclofen to Prevent Post-Traumatic Stress Disorder: 5 Years Follow-up of the BACLOREA Randomized Trial
- ClinicalTrials.gov ID
- NCT05877807
- Acronym / sponsor ID
- BACLO-PTSD / RC21_0251
- Conditions
- Alcoholism, Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : BACLOFEN | – | Drug: BaclofenPatient will receive baclofen caps |
| Placebo Comparator : PLACEBO | – | Other: PlaceboPatient will receive placebo caps (lactose) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.Non-cerebrodamaged patients admitted to intensive care regardless of the causal pathology with:
- 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
Key exclusion criteria (2 listed)
- Patients who died during the study or within 5 years of inclusion will not be included. Also, patients who withdrew their consent after inclusion in the Balorea study will not be included. Similarly, patients refusing to answer telephone questionnaires will not be included. Known deceased patients will not be contacted.
- Patients under guardianship/guardianship at the time of initial inclusion or since the end of the Balorea study will not be contacted and therefore will not be analyzed in this research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaclofenDaily 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. | Drug | Experimental : BACLOFEN |
| PlaceboDaily 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. | Other | Placebo Comparator : PLACEBO |
Primary outcome
Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R)
Time frame: 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.
5 secondary outcomes
Evaluation of the quality of life using the questionnaire European Quality of Life-5 Dimensions (EQ-5D)
Time frame: 5 years post hospitalization
Health assessement with the Short Form (SF-36 Quiz)
Time frame: 5 years post hospitalization
Screen for anxiety and depressive disorders with Hospital Anxiety and Depression scale (HAD Quiz)
Time frame: 5 years post hospitalization
Evaluation of the Posttraumatic stress disorder (PCL-S Quiz)
Time frame: 5 years post hospitalization
Assessment of patient Habits
Time frame: 5 years post hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Derived from this study: PubMed 41507241Bouras 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim ASEHNOUNE, PU-PH principal investigator
Nantes University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism and Post Traumatic Stress Disorder, run by Nantes University Hospital at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the incidence of post-traumatic stress syndrome using the Revised Event Impact Scale (IES-R) (time frame: 5 years post hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.