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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 week study period |
| Treatment response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cleo L Crunelle | Contact | +32 477 77 22 | cleo.crunelle@vub.be |
| Name | Affiliation | Role |
|---|---|---|
| Cleo L Crunelle | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
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.
| 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. | At start and after 6 week study period |
| Craving scores | Craving scores measured by self-report VAS for craving and the DDQ. | 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. | At start and after 6 week study period |
| Drinking motives | Drinking motives measured using the DMQ-SF. | At start of 6 week study period |
| Side effects | Side effects assessed by open end questions | Weekly during 6 week study period |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |