Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT03018704
Eligibility Criteria:
Inclusion Criteria:
1. self-identification as African American;
2. age 18 to 70 years, inclusive;
3. average weekly ethanol consumption of \>24 standard drinks for men or \>18 standard drinks for women, with a weekly average of \> 2 heavy drinking days (men: \> 5 standard drinks; women: \> 4 standard drinks) during the month before screening;
4. a current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria);
5. expressed goal to reduce or stop drinking;
6. able to read English at the 6th grade or higher level and without gross cognitive impairment;
7. women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment
8. willing and able to provide signed, informed consent to participate in the study.
Exclusion Criteria:
1. a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of \>110% or a transaminase elevation \>300% of normal;
2. history of nephrolithiasis;
3. history of glaucoma;
4. current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, antisocial personality disorder, or imminent suicide or violence risk);
5. current moderate-to-severe alcohol withdrawal requiring pharmacological treatment (see Section D.4.a. regarding alcohol detoxification);
6. current DSM-IV diagnosis of drug use disorder (other than nicotine or cannabis) or a urine drug screen positive for recent use of opioids, cocaine, or amphetamines (may be repeated once and if the result is negative on repeat it is not exclusionary);
7. a history of hypersensitivity to TOP;
8. current regular treatment with more than one antidepressant or any treatment with a tricyclic antidepressant;
9. current treatment with a psychotropic medication (with the exception of antidepressants where monotherapy is allowable), including medications that, when combined with alcohol or TOP, present a risk of overdose or significant adverse effect (e.g., chronic opioid use) (of note we will allow subjects to discontinue medications that have no demonstrated therapeutic effect in order to enroll - amount of time off of the medication will be a clinical decision left to the discretion of the study physician investigators);
10. current treatment with TOP or a medication approved for AUD;
11. considered to be unsuitable candidates for receipt of an investigational drug;
12. treatment with carbonic anhydrase inhibitors, due to the added risk of metabolic acidosis,
13. Body Mass Index (BMI) of less than 18.5.
14. untreated gout as topiramate has been shown in one study to increase uric acid.
15. current treatment with dolutegravir.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03018704
Study Brief:
Protocol Section:
NCT03018704