Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06835907

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

Led by Universitair Ziekenhuis Brussel · Updated on 2025-02-19

58

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of baclofen for treating alcohol use disorder (AUD) in adults, including those with or without anxiety symptoms. It focuses on whether patients with higher anxiety levels experience more days of abstinence and other differences such as drinking behavior, response to treatment, anxiety reduction, craving, motives, and side effects. Participants are already using baclofen as part of their usual care for AUD. The study involves a single group where baclofen is given as standard care, with dosage adjusted by the treating doctor based on tolerance. The intervention itself consists of completing various questionnaires throughout a 6-week period. These questionnaires assess alcohol use, anxiety, craving, autonomic symptoms, drinking motives, and side effects. Participants will answer these questionnaires weekly or bi-weekly over the 6 weeks, starting from hospitalization or baclofen initiation. Researchers will measure the number of days participants remain abstinent each week and evaluate changes in drinking behavior, anxiety scores, autonomic responses, craving levels, treatment response, and side effects. This study spans a total of 6 weeks with no additional treatment interventions beyond standard care baclofen.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosed with alcohol use disorder according to DSM-5 criteria
  • Able to understand and provide written consent
  • Already receiving baclofen or started baclofen at hospitalization
  • Desire to achieve alcohol abstinence
Not Eligible

You will not qualify if you...

  • Having another substance use disorder besides nicotine or cannabis
  • Significant psychiatric illness requiring medication changes in the last 30 days
  • Significant medical diseases posing risk to continuing baclofen
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants complete questionnaires related to alcohol use, anxiety, and craving while receiving baclofen as part of routine care.

Weekly visits during the 6 week study period

Trial Site Locations

Total: 1 location

1

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

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Research Team

C

Cleo L Crunelle

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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