RecruitingNot ApplicableNCT06835907

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

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


Sponsor

Universitair Ziekenhuis Brussel

Enrollment

58 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

Interventions

OTHERQuestionnaires

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).


Locations(1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

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NCT06835907


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