NCT06835907 Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study
| NCT ID | NCT06835907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2029-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 58 participants in total. It began in 2024-10-28 with a primary completion date of 2029-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Cleo L Crunelle
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT06835907 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835907 currently recruiting?
Yes, NCT06835907 is actively recruiting participants. Contact the research team at cleo.crunelle@vub.be for enrollment information.
Where is the NCT06835907 trial being conducted?
This trial is being conducted at Jette, Belgium.
Who is sponsoring the NCT06835907 clinical trial?
NCT06835907 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Cleo L Crunelle at Universitair Ziekenhuis Brussel. The trial plans to enroll 58 participants.