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NCT Number: NCT06835907

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

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.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Anxiety Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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 outcomes

  1. Number of days abstinent

    Time frame: 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 outcomes

  1. Any drinking

    Time frame: 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.

  2. Treatment response

    Time frame: 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.

  3. Autonomic symptom responses

    Time frame: 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.

  4. Craving scores

    Time frame: 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.

  5. Anxiety score reduction

    Time frame: At start and after 6 week study period

    Reduction in anxiety score measured using the DASS-21.

  6. Drinking motives

    Time frame: At start of 6 week study period

    Drinking motives measured using the DMQ-SF.

  7. Side effects

    Time frame: Weekly during 6 week study period

    Side effects assessed by open end questions

Study contacts

Contact information is provided by the study sponsor or research team.

Cleo L Crunelle

CONTACT

[email protected]

+32 477 77 22

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Acronym: BAC2

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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