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Baclofen safety study halted early: what we learned

NCT ID NCT02596763

Knowledge-focused Sponsor: University Hospital, Lille 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracked 239 adults in France taking baclofen for alcohol use disorder. Researchers called participants monthly for a year to see how many stopped the drug due to side effects. The goal was to better understand which side effects are caused by baclofen versus other factors like alcohol or other medications.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

239 people

The number who actually took part.

Started

Dec 2015

Finished

Dec 2018

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: * Aged 18 or more and under 80 years * Receiving an off-label baclofen treatment for alcohol use disorder for less than 15 days * Mentally and physically able to participate in telephone interviews * Reachable by phone * Living in the Hauts-de-France or Normandie French regions * Beneficiary of a health insurance plan * Informed and signed consent before the beginning of the study. Exclusion Criteria: * Baclofen prescriber not registered as investigator or not previously labeled for receiving consent, or not located in the regions of Hauts-de-France or Normandie * Patient with ICD-10 criteria for other substance dependence (except tobacco) in the past three months. * Patient not reachable by phone or unable to correctly understand the French language * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

alcohol abuse

As listed by the trial registrant

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

Alcohol use disorder

Contacts and locations

Locations

  • Centres de Soins, d'Accompagnement et de Prévention en Addictologie (CSAPA) Le Cèdre Bleu

    Armentières, 59280, France

  • Etablissement Public de Santé Mentale (EPSM)

    Lille, 59000, France

  • Hospital Center

    Saint-Pol-sur-Ternoise, 62130, France

  • Hospital Center

    Tourcoing, 59200, France

  • Hospital Center

    Valenciennes, 59300, France

  • Hospital Center

    Abbeville, 80100, France

  • Hospital Center

    Arras, 62000, France

  • Hospital Center

    Boulogne, 62200, France

  • Hospital Center

    Carvin, 62220, France

  • Hospital Center

    Clermont, 60600, France

  • Hospital Center

    Dunkirk, 59300, France

  • Hospital Center

    Ham, 80400, France

  • Hospital Center

    Hazebrouck, 59190, France

  • Hospital Center

    Lens, 62300, France

  • Hospital Center

    Roubaix, 59100, France

  • Hospital Center

    Saint-Amand-les-Eaux, 59230, France

  • Service d'Aide aux Toxicomanes (SATO-Picardie)

    Beauvais, 60000, France

  • University Hospital of Caen

    Caen, France

  • University Hospital of Rouen

    Rouen, France

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