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

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Alcohol Use Disorder (AUD)

Treatments: Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT06835907

1432024000205

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Baclofen

Experimental group

Description:

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.

Treatment:

Other: Questionnaires