Actively Recruiting
Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder and Comorbid Anxiety Symptoms
Led by Universitair Ziekenhuis Brussel · Updated on 2025-02-19
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of baclofen for treating alcohol use disorder (AUD) in adults, including those with or without anxiety symptoms. It focuses on whether patients with higher anxiety levels experience more days of abstinence and other differences such as drinking behavior, response to treatment, anxiety reduction, craving, motives, and side effects. Participants are already using baclofen as part of their usual care for AUD. The study involves a single group where baclofen is given as standard care, with dosage adjusted by the treating doctor based on tolerance. The intervention itself consists of completing various questionnaires throughout a 6-week period. These questionnaires assess alcohol use, anxiety, craving, autonomic symptoms, drinking motives, and side effects. Participants will answer these questionnaires weekly or bi-weekly over the 6 weeks, starting from hospitalization or baclofen initiation. Researchers will measure the number of days participants remain abstinent each week and evaluate changes in drinking behavior, anxiety scores, autonomic responses, craving levels, treatment response, and side effects. This study spans a total of 6 weeks with no additional treatment interventions beyond standard care baclofen.
CONDITIONS
Brief Title
Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with alcohol use disorder according to DSM-5 criteria
- Able to understand and provide written consent
- Already receiving baclofen or started baclofen at hospitalization
- Desire to achieve alcohol abstinence
You will not qualify if you...
- Having another substance use disorder besides nicotine or cannabis
- Significant psychiatric illness requiring medication changes in the last 30 days
- Significant medical diseases posing risk to continuing baclofen
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants complete questionnaires related to alcohol use, anxiety, and craving while receiving baclofen as part of routine care.
Weekly visits during the 6 week study period
Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
C
Cleo L Crunelle
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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