Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Using baclofen to treat anxiety and alcohol use disorder

Official title: Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder (AUD) and Comorbid Anxiety Symptoms

Run by Universitair Ziekenhuis Brussel · NCT06835907 · Data updated 2026-11-12

This study is testing if baclofen can help people with alcohol use disorder who also have anxiety feel better and drink less.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment58 (estimated)
SponsorUniversitair Ziekenhuis Brussel
Academic / other
Locations1 site (Jette, Brussels Capital)
StatusRecruiting
StartedOctober 28, 2024
Main results expectedDecember 30, 2029
Study endsDecember 30, 2029
Registry record updatedFebruary 19, 2025
Trial IDNCT06835907 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with alcohol use disorder who are already receiving baclofen and have a desire for alcohol abstinence.

Probably not a fit

Patients with concurrent substance use disorders or significant psychiatric illnesses requiring pharmacotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of baclofen in treating alcohol use disorder (AUD) among patients, particularly focusing on those with varying levels of anxiety symptoms. Participants who are already on baclofen will complete questionnaires over a six-week period to assess their drinking behaviors, anxiety levels, and other related factors. The study aims to determine if higher anxiety symptoms correlate with fewer abstinent days and other treatment outcomes. By analyzing these responses, the trial seeks to provide insights into the relationship between anxiety and alcohol use in patients receiving baclofen.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic approach for treating alcohol use disorder, especially in patients with anxiety.

How similar studies have gone: While the use of baclofen for AUD has been explored, this specific focus on anxiety symptoms in conjunction with AUD treatment is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Meeting DSM-5 criteria for AUD
* Able to understand and provide written consent
* Already receiving baclofen or started with baclofen at start of hospitalization
* Therapeutic desire towards alcohol abstinence

Exclusion Criteria:

* Concurrent substance use disorder other than nicotine or cannabis
* Clinically significant psychiatric illness that requires pharmacotherapy, unless stable and no changes in medication has been made in the last 30 days
* Clinically significant medical diseases that may pose a risk to continuing baclofen use
* Pregnant or currently breastfeeding women

Where it's running

  • Universitair Ziekenhuis Brussel
    Jette, Brussels Capital, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.