Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study

Recruiting now · Not applicable

Conditions studied: Alcohol Use Disorder (AUD)

In brief

The goal of this clinical trial is to determine the efficacy of baclofen for the treatment of alcohol use disorder (AUD) in patients with or without comorbid anxiety symptoms. The main questions it aims to answer are: * Do we see more abstinent days after the study period in patients with high anxiety symptoms compared to low anxiety symptoms? * Do we observe additional differences between patients with high- and low anxiety symptoms in: any drinking at the end of treatment (yes/no), number of patients who respond to treatment, anxiety score reduction, autonomic responses, craving scores, drinking motives and side effects? Participants already taking baclofen as part of routine clinical care for treatment of AUD will be asked to answer several questionnaires over a 6 week study period.

Key facts

Study ID

NCT06835907

Run by

Universitair Ziekenhuis Brussel

People needed

58

Starts

2024-10-28

Expected to finish

2029-12-30

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Universitair Ziekenhuis Brussel — Jette, Brussels Capital, Belgium (enrolling)

Full record on ClinicalTrials.gov

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