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Can a muscle relaxant curb alcoholism? new trial results are in

NCT ID NCT01604330

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether the drug baclofen, typically used for muscle spasms, can help people with alcoholism reduce their drinking. Over 300 adults who wanted to cut back or quit took either baclofen or a placebo for a year. The main goal was to see if more people on baclofen achieved low-risk drinking or abstinence according to WHO guidelines.

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)
What this could lead to
If it works, this could offer a new medication option to help people with alcoholism drink less or stay abstinent.
What could go wrong
This is a completed Phase 2/3 trial, but results may not apply to everyone. Baclofen can cause side effects like drowsiness and muscle weakness, and the optimal dose is still unclear.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

323 people

The number who actually took part.

Started

May 2012

Finished

Oct 2015

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 65 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: * Patient coming for a problem with alcohol (alcohol at high risk during the past three months (at least two times during each month) according to the WHO standards;. i.e.: in women more than 40 g per day or 280 g per week or more of 40 g at once; the man more than 60 g per day or 420 g per week or more than 60 g in once, and expressing the desire to be abstinent or to have a consumption to low level of risk). * Volunteer to participate in the trial and having given his consent written after appropriate information * Patient having no treatment for the maintenance of abstinence (acamprosate, naltrexone) and the prevention of relapse (disulfiram) for at least 15 days before the beginning of the trial * Patient informed about the possibility of drowsiness in relation to the treatment and the associated risks to drive vehicles (motorized or not), the use of machines (including domestic use or recreation) and the execution of tasks requiring attention and precision * Including woman of childbearing age (but taking effective contraception). Exclusion Criteria: * Patient taking already baclofen or having taken baclofen * Patient pregnant, lactating, or childbearing years in the absence of effective contraception * Patient with porphyria * Patient with Parkinson's disease * Patient with severe psychiatric pathology (psychosis, including schizophrenia and bipolar disorders) that can compromise the observance * Patient with organic disease serious enough to not to allow its inclusion in the study according to the opinion of the investigator * Patient homeless * Patient without social cover * Patient unable to properly follow-up book, cannot commit to one year of follow-up * Patient with a contraindication to taking baclofen (intolerance to gluten by the presence of wheat starch * Patient with a severe intolerance known about the lactose

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Paris Descartes University

    Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.