Alcohol Use Disorder (AUD)
Conditions
Keywords
Alcohol use disorder (AUD), Baclofen, Anxiety
Brief 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.
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).
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days abstinent | Weekly during 6 week study period | Number of days abstinent during baclofen treatment between AUD patients with and without comorbid anxiety, as measured by the TLFB. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any drinking | After 6 week study period | 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. |
| Treatment response | After 6 week study period | 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. |
| Autonomic symptom responses | At start and after 6 week study period | Autonomic symptom responses measured by the COMPASS-31 assessing 6 domains of autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastro-intestinal, bladder and pupillomotor. |
| Side effects | Weekly during 6 week study period | Side effects assessed by open end questions |
| Anxiety score reduction | At start and after 6 week study period | Reduction in anxiety score measured using the DASS-21. |
| Drinking motives | At start of 6 week study period | Drinking motives measured using the DMQ-SF. |
| Craving scores | Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period | Craving scores measured by self-report VAS for craving and the DDQ. |
Countries
Belgium
Contacts
Primary ContactCleo L Crunelle
Outcome results
None listed