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Can a muscle relaxant keep heavy drinkers calm on breathing machines?

NCT ID NCT02723383

Prevention Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Heavy drinkers who need a breathing machine in intensive care often become agitated, which can lead to pulling out tubes, falling, or harming themselves or staff. This Phase 3 trial tests whether baclofen, a drug that calms the nervous system, can prevent these dangerous events better than a placebo. Researchers will enroll 314 adults who drink above recommended limits and are expected to need mechanical ventilation for more than a day. The study measures agitation-related problems, time on the ventilator, length of ICU stay, and sedative and painkiller use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baclofen, a muscle relaxant drug also used to reduce alcohol cravings
What this could lead to
If baclofen works, intensive care teams could have a routine drug to keep heavily drinking patients calm and safe while they are on breathing machines.
What could go wrong
Baclofen can cause sedation and confusion, which may be hard to separate from alcohol withdrawal in very sick patients. The trial may show no benefit, or the results may not apply to lighter drinkers or non-ICU settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

314 people

The number who actually took part.

Started

Jun 2016

Finished

Aug 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol withdrawal delirium Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcoholism

Contacts and locations

Locations

  • CH Le Mans

    Le Mans, France

  • CHD La Roche Sur YON

    La Roche-sur-Yon, France

  • CHR Saint Nazaire

    Saint-Nazaire, France

  • CHRU Tours Bretonneau

    Tours, France

  • CHU ANGERS - réanimation chirurgicale

    Angers, France

  • CHU MONTPELLIER - Lapeyronie

    Montpellier, France

  • CHU NANTES - réanimation chirurgicale

    Nantes, France

  • CHU NANTES -réanimation médicale

    Nantes, France

  • CHU de Brest Réanimation Chirurgicale

    Brest, France

  • CHU de Brest Réanimation Médicale

    Brest, France

  • CHU de Caen Réanimation Médicale

    Caen, France

  • Centre Hospitalier de Bretagne Sud Réanimation Polyvalente Lorient

    Lorient, France

  • Ch Cornouaille

    Quimper, France

  • Chu Montpellier

    Montpellier, France

  • Chu Poitiers

    Poitiers, France

  • Chu Rennes

    Rennes, France

  • Chu Tours

    Tours, France

  • Hopital Saint Antoine

    Paris, France

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