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AlcoholismPhase 3BACLOREANCT02723383

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

A Phase 3 study testing BACLOFEN in people with Alcoholism, run by Nantes University Hospital at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Alcoholism
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
314 participants
Where
18 sitesFrance
Study dates
27 Jun 2016to 14 Aug 2019
Phase
Phase 3
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

Who may be able to join

  • Adults from 18 to 80 years old with an estimated alcohol intake of:
  • 14 units of alcohol per week during the month before hospitalisation for men aged 18 to 64
  • 7 units of alcohol per week during the month before hospitalisation for women or men older than 65.
  • AND Intubated, ventilated with an expected duration of mechanical ventilation> 24 hours at least

Who cannot join

  • Hospitalization > 7 days
  • Baclofen administration before ICU admission (personal treatment or single administration)
  • Pregnancy
  • Porphyria
  • Burned on ICU admission
  • Personal treatment including Gamma-hydroxybutyric acid (Alcover/Xyrem)
Show all 20Show fewer
  • Recent stroke or subarachnoid haemorrhage or head trauma with radiological evidence
  • Recent or old paraplegia or tetraplegia
  • Cardiac arrest with resuscitation manoeuvres before or after ICU admission
  • Contraindication to Enteral drug administration for longer than 24 hours
  • Lack of social protection
  • Hypersensitivity to Baclofen
  • Coeliac disease
  • Refractory epilepsy
  • Dementia, schizophrenia, Bipolar disorder or severe depression.
  • Parkinson's disease
  • Health care limitation owing to pejorative prognosis
  • Tracheotomy on ICU admission
  • Patients under guardianship or trusteeship
  • Patients already enrolled in interventional study

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU ANGERS - réanimation chirurgicale

    Angers

  • CHU de Brest Réanimation Chirurgicale

    Brest

  • CHU de Brest Réanimation Médicale

    Brest

  • CHU de Caen Réanimation Médicale

    Caen

  • CHD La Roche Sur YON

    La Roche-sur-Yon

  • CH Le Mans

    Le Mans

  • Centre Hospitalier de Bretagne Sud Réanimation Polyvalente Lorient

    Lorient

  • CHU MONTPELLIER - Lapeyronie

    Montpellier

  • Chu Montpellier

    Montpellier

  • CHU NANTES - réanimation chirurgicale

    Nantes

  • CHU NANTES -réanimation médicale

    Nantes

  • Hopital Saint Antoine

    Paris

  • Chu Poitiers

    Poitiers

  • Ch Cornouaille

    Quimper

  • Chu Rennes

    Rennes

  • CHR Saint Nazaire

    Saint-Nazaire

  • CHRU Tours Bretonneau

    Tours

  • Chu Tours

    Tours

Other trials in France

About this study

Official title: Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness, extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.

Methods/Design: This prospective, randomised, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary objective is to determine whether Baclofen is more efficient than placebo in preventing restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects are defined as unplanned extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be guided by creatinine clearance assessment once a day.

Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA is a randomised study assessing the capacity of Baclofen to prevent agitation in mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is expected to end in December 2019.

Conditions
Alcoholism
Being tested
BACLOFEN, PLACEBO
Keywords
alcoholism, intensive care, Baclofen, restlessness, Delirium tremens, Alcohol withdrawal syndrome
Medical subject headings
Alcoholism, Psychomotor Agitation, Alcohol Withdrawal Delirium

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.

  • PLACEBODrug

    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 groups in NCT02723383
Study groupRoleWhat they receive
BACLOFENExperimentalpatient will receive baclofen caps
Receives: Drug: BACLOFEN
PLACEBOPlacebo comparatorpatient will receive placebo caps (lactose)
Receives: Drug: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence (yes or no) of agitation-related adverse events

    Occurrence (yes or no) of agitation-related adverse events during treatment/placebo administration with at least one sign out of the following:

    • Unplanned extubation
    • Medical disposal removal
    • Falling out of bed
    • ICU runaway
    • Immobilization device removal
    • Self-aggression or aggression towards medical staff.

    Measured: at the end of treatment (22 days max)

Secondary outcomes (17)

  1. Adverse event (yes or no) related to agitation

    Measured: within 28 days of ICU admission

  2. Extubation failure defined as reintubation

    Measured: within the next 48 hours after extubation

  3. Tracheotomy for failure of mechanical ventilation weaning during hospitalization

    Measured: an average of 28 days

  4. Infections acquired in the ICU: Urinary infection, pneumonia, catheter infection or bacteraemia during hospitalization

    Measured: an average of 28 days

  5. Total doses of sedatives and painkillers received in the ICU

    Measured: within 28 days of ICU admission

  6. Riker Sedation -Agitation Scale (SAS) in the ICU

    Measured: within 28 days of ICU admission

  7. Daily CIWA-Ar alcohol withdrawal score

    Measured: during the week following extubation

  8. Duration of mechanical ventilation during hospitalization

    Measured: an average of 28 days

  9. Ventilation free days (VFD)

    Measured: at day 28

  10. Length of ICU stay

    Measured: within 90 days

  11. Length of total hospitalisation

    Measured: within 90 days

  12. Death in ICU

    Measured: at days 28 and 90

  13. Death during hospital stay during hospitalization

    Measured: within 90 days

  14. Number of adverse event (s) per patient occurring in ICU from Day 1 to Day 28

    Measured: until Day 28

  15. Agitation requiring rapid intravenous or intramuscular administration of an hypnotic or neuroleptic (bolus)

    Measured: until Day 28

  16. Reintubation due to restlessness or withdrawal syndrome

    Measured: until Day 28

  17. Agitation and mortality in ICU at Day 28

    Measured: at Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2016 (estimated)
  2. Study start27 Jun 2016
  3. Primary completion14 Aug 2019
  4. Study completion14 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02723383
Sponsor's protocol ID
RC15_0036
Acronym
BACLOREA
Status last verified
Jan 2020
First submitted
3 Mar 2016
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Vourc'h M, Feuillet F, Mahe PJ, Sebille V, Asehnoune K; BACLOREA trial group. Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial. Trials. 2016 Aug 19;17(1):415. doi: 10.1186/s13063-016-1539-2.

    PubMed 27542731

  • Vourc'h M, Garret C, Gacouin A, Lacherade JC, Jonas M, Klouche K, Ferrandiere M, Jaber S, Flet L, Dailly E, Pouplet C, Maamar A, Reignier J, Roquilly A, Feuillet F, Mahe PJ, Asehnoune K; BACLOREA study group. Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):732-741. doi: 10.1001/jama.2021.0658.

    PubMed 33620407

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BACLOFEN in people with Alcoholism, run by Nantes University Hospital at 18 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 4 inclusion and 20 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Occurrence (yes or no) of agitation-related adverse events (time frame: at the end of treatment (22 days max)). 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 NCT02723383, which also lists 2 linked publications.

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 14 Sep 2026.

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