Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder (AUD) and Comorbid Anxiety Symptoms
Overview
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.
Interventions
- 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).
Primary outcome measures
- Number of days abstinent [Time frame: Weekly during 6 week study period]
Secondary outcome measures (7)
- Any drinking [Time frame: After 6 week study period]
- Treatment response [Time frame: After 6 week study period]
- Autonomic symptom responses [Time frame: At start and after 6 week study period]
- Craving scores [Time frame: Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period]
- Anxiety score reduction [Time frame: At start and after 6 week study period]
- Drinking motives [Time frame: At start of 6 week study period]
- Side effects [Time frame: Weekly during 6 week study period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Universitair Ziekenhuis Brussel — Jette
Identifiers
NCT: NCT06835907 · 1432024000205