Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study (BAC2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder (AUD)
• Intervention / Treatment: Other: Questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cleo L Crunelle; Phone Number: +32 477 77 22; Email: cleo.crunelle@vub.be

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Baclofen; SIngle arm study, investigating baclofen as standard care uptitrated to maximal tolerated dosage upon clinical judgment and not part of the trial. The active intervention involves questionnaires.

Other: Questionnaires; Questionnaires include: the Alcohol Use Disorder Identification Test (AUDIT), Composite Autonomic Symptom Score (COMPASS-31), Depression Anxiety Stress Scale (DASS-21), Drug Desire Questionnaire (DDQ), Drinking Motives Questionnaire short form (DMQ-SF), Mini International Neuropsychiatric Interview (MINI), PROMIS-alcohol, Timeline Follow Back (TLFB) and Visual Analog Scale for craving (VAS).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any drinking	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.	After 6 week study period
Treatment response	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.	After 6 week study period
Autonomic symptom responses	Autonomic symptom responses measured by the COMPASS-31 assessing 6 domains of autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastro-intestinal, bladder and pupillomotor.	At start and after 6 week study period
Craving scores	Craving scores measured by self-report VAS for craving and the DDQ.	Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period
Anxiety score reduction	Reduction in anxiety score measured using the DASS-21.	At start and after 6 week study period
Drinking motives	Drinking motives measured using the DMQ-SF.	At start of 6 week study period
Side effects	Side effects assessed by open end questions	Weekly during 6 week study period

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Cleo L Crunelle, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Baclofen; Alcohol use disorder (AUD)
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking
• Other Study ID Numbers: 1432024000205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No