The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study

Eligibility Criteria

• 1. Four or more standard drinks on four or more occasions in the prior 30 days.
• 2. Seeking AUD treatment.
• 3. Aged 18-65 years.
• 4. DSM-5 diagnosis of AUD.
• 5. Ability to read and speak English.
• 6. Ability to provide written informed consent.
• 7. Breath alcohol of 0.00 during informed consent.
• 8. Provision of at least 1 EtG-positive urine test at any time during the induction period.
• 9. Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and
• 10. Attended at least 4 of 6 visits during the induction period.
• 1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal;
• 2. Currently receiving any pharmacotherapy for alcohol or in the past 30 days.
• 3. Current DSM-5 diagnosis of severe substance use disorder other than nicotine.
• 4. Suicide attempt in the last 20 years.
• 5. History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
• 6. Systemic autoimmune disease.
• 7. History of current seizure disorder (e.g., are they receiving medication currently for their seizures, have they ever been told by their provider that they have epilepsy, or do they have a history of recurring seizures in the last 5 years?).
• 8. Current clinically significant blood dyscrasia.
• 9. History of clinically significant renal calculi or renal failure; renal compromise (defined by an elevation of serum creatinine above our laboratory's limit of normal).
• 10. History of traumatic brain injury (TBI; e.g., ever been told by a provider that they had a moderate or severe TBI, lost consciousness for 30 minutes or longer or had a post-traumatic amnesia lasting a day or longer).
• 11. Any other current, clinically significant physical disease \[i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease\] on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels (i.e., AST and ALT) or direct bilirubin, and
• 12. Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.