Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework

18520-001

A phase II randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of zonisamide (ZON) to decrease alcohol use among treatment-seeking adults with an alcohol use disorder (AUD).

2022-01-07

2025-08-01

2025-08-01

Recruiting

Early phase I

205

Inclusion 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. Exclusion Criteria: 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A phase II randomized, double-blind, placebo-controlled clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 205, 'type': 'ESTIMATED'}}

2023-04-27