Using baclofen to treat anxiety and alcohol use disorder

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

NA · Universitair Ziekenhuis Brussel · NCT06835907

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

Quick facts

PhaseNA
Study typeInterventional
Enrollment58 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorUniversitair Ziekenhuis Brussel (other)
Locations1 site (Jette, Brussels Capital)
Trial IDNCT06835907 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility criteria

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 this trial is running

Jette, Brussels Capital

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Alcohol Use Disorder, Alcohol use disorder, Baclofen, Anxiety

Last reviewed 2026-05-15 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.