Alcohol Use Disorder (AUD)BAC2NCT06835907
Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study
A study testing Questionnaires in people with Alcohol Use Disorder (AUD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Oct 2024to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
About this study
Official title: Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder (AUD) and Comorbid Anxiety Symptoms
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)
- Being tested
- Questionnaires
- Keywords
- Alcohol use disorder (AUD), Baclofen, Anxiety
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days abstinent
Number of days abstinent during baclofen treatment between AUD patients with and without comorbid anxiety, as measured by the TLFB.
Measured: Weekly during 6 week study period
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: At start and after 6 week study period
Craving scores
Craving scores measured by self-report VAS for craving and the DDQ.
Measured: 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.
Measured: At start and after 6 week study period
Drinking motives
Drinking motives measured using the DMQ-SF.
Measured: At start of 6 week study period
Side effects
Side effects assessed by open end questions
Measured: Weekly during 6 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start28 Oct 2024
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cleo L Crunelle, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835907
- Sponsor's protocol ID
- 1432024000205
- Acronym
- BAC2
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder (AUD) and Comorbid Anxiety Symptoms
- ClinicalTrials.gov ID
- NCT06835907
- Acronym / sponsor ID
- BAC2 / 1432024000205
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol use disorder (AUD), Baclofen, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Experimental | Other: QuestionnairesSIngle 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires 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). | Other | Baclofen |
Primary outcome
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.
7 secondary outcomes
Any drinking
Time frame: After 6 week study period
Treatment response
Time frame: After 6 week study period
Autonomic symptom responses
Time frame: At start and after 6 week study period
Craving scores
Time frame: Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period
Anxiety score reduction
Time frame: At start and after 6 week study period
Drinking motives
Time frame: At start of 6 week study period
Side effects
Time frame: Weekly during 6 week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cleo L Crunelle principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Alcohol Use Disorder (AUD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cleo L Crunelle (+32 477 77 22, cleo.crunelle@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days abstinent (time frame: Weekly during 6 week study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.