Topiramate Treatment of Alcohol Use Disorders in African Americans
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Topiramate; placebo
Intervention description: anticonvulsant medication. The medication was dosed twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable.; inactive medication. the doses of placebo were titrated the same as the active intervention.
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: alcoholism; treatment

Summary:

      The focus of this application is on the improvement of services for African American (AAs)
      Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate
      as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than
      European Americans (EAs), AAs have significantly higher rates of mortality from a variety of
      alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the
      higher rates of morbidity and mortality, pharmacological treatments are understudied in this
      population and there is some evidence that medications are less preferred and less effective
      in AAs.
    

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.