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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder (AUD)

In brief

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).

Key facts

Study ID

NCT05134857

Run by

Washington State University

People needed

205

Starts

2022-01-07

Expected to finish

2027-08-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Four or more standard drinks on four or more occasions in the prior 30 days.
• Seeking AUD treatment.
• Aged 18-65 years.
• DSM-5 diagnosis of AUD.
• Ability to read and speak English.
• Ability to provide written informed consent.
• Breath alcohol of 0.00 during informed consent.
• Provision of at least 1 EtG-positive urine test at any time during the induction period.
• Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and
• Attended at least 4 of 6 visits during the induction period.

You may not qualify if…

• 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;
• Currently receiving any pharmacotherapy for alcohol or in the past 30 days.
• Current DSM-5 diagnosis of severe substance use disorder other than nicotine.
• Suicide attempt in the last 20 years.
• History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
• Systemic autoimmune disease.
• 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?).
• Current clinically significant blood dyscrasia.
• 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).
• 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).
• 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
• Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.

Where it is running

• Washington State University — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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