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

NCT06835907 | Recruiting

• 1 other identifier: 1432024000205
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol use disorder (AUD); Baclofen; Anxiety

Outcome Measures

Primary Outcomes (1)

• Number of days abstinent

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

  Weekly during 6 week study period

Secondary Outcomes (7)

• Any drinking

  After 6 week study period

• Treatment response

  After 6 week study period

• Autonomic symptom responses

  At start and after 6 week study period

• Craving scores

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

• Anxiety score reduction

  At start and after 6 week study period

Study Arms (1)

Baclofen

EXPERIMENTAL

SIngle arm study, investigating baclofen as standard care uptitrated to maximal tolerated dosage upon clinical judgment and not part of the trial. The active intervention involves questionnaires.

Other: Questionnaires

Interventions

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).

Baclofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Cleo L Crunelle

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cleo L Crunelle

CONTACT

+32 477 77 22; cleo.crunelle@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: October 28, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

BE (1)