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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder (AUD)

• Registration Number: NCT06835907
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-28
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2029-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of days abstinent	Weekly during 6 week study period	Number of days abstinent during baclofen treatment between AUD patients with and without comorbid anxiety, as measured by the TLFB.

Secondary Outcome Measures

Name	Time	Method
Any drinking	After 6 week study period	Any drinking (i.e. drinking yes or no at the end of treatment) between AUD patients with and without comorbid anxiety, as measured by the TLFB.
Treatment response	After 6 week study period	Number of individuals who respond to baclofen treatment, defined as reducing their alcohol use by more than 30% over the 6 week study period, as measured by the TLFB.
Autonomic symptom responses	At start and after 6 week study period	Autonomic symptom responses measured by the COMPASS-31 assessing 6 domains of autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastro-intestinal, bladder and pupillomotor.
Craving scores	Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period	Craving scores measured by self-report VAS for craving and the DDQ.
Anxiety score reduction	At start and after 6 week study period	Reduction in anxiety score measured using the DASS-21.
Drinking motives	At start of 6 week study period	Drinking motives measured using the DMQ-SF.
Side effects	Weekly during 6 week study period	Side effects assessed by open end questions

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium