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

Universitair Ziekenhuis Brussel58 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alcohol Use Disorder (AUD)

Interventions

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of days abstinent

Number of days abstinent during baclofen treatment between AUD patients with and without comorbid anxiety, as measured by the TLFB.

Time frame: Weekly during 6 week study period

Secondary Outcomes

Any drinking

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.

Time frame: After 6 week study period

Treatment response

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.

Time frame: After 6 week study period

Autonomic symptom responses

Autonomic symptom responses measured by the COMPASS-31 assessing 6 domains of autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastro-intestinal, bladder and pupillomotor.

Time frame: At start and after 6 week study period

Craving scores

Craving scores measured by self-report VAS for craving and the DDQ.

Time frame: Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period

Anxiety score reduction

Reduction in anxiety score measured using the DASS-21.

Time frame: At start and after 6 week study period

Drinking motives

Drinking motives measured using the DMQ-SF.

Time frame: At start of 6 week study period

Side effects

Side effects assessed by open end questions