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The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT05134857•Washington State University

Summary

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).

Detailed Description

This project focuses on the efficacy of a promising pharmacotherapy (ZON) for AUDs using a placebo-controlled design that will rigorously measure alcohol use and medication adherence. Results will guide novel mechanistic targets to better capture the heterogeneity within AUDs. This project will evaluate the ability of ZON to treat the alcohol use disorder. The investigators hypothesize that the group assigned to ZON associated with the standard treatment (ZON+ST) will yield lower rates of biochemically verified alcohol use, fewer self-reported drinks per day, and fewer heavy drinking days during the 12-week treatment and 1-year follow-up periods, relative to the placebo associated with the standard treatment (PLO+ST) group.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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).
+2 more criteria

Locations (1)

Washington State University

Spokane, Washington, United States

Key Dates

Start Date

January 7, 2022

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

August 13, 2024

Enrollment

205

ESTIMATED participants

Conditions

Alcohol Use Disorder (AUD)

Interventions

Zonisamide

DRUG

Placebo

DRUG

Contacts

Abigail L Bowen, MS

CONTACT

(425) 736-1354 abigail.bowen@wsu.edu

Sterling McPherson, PhD

CONTACT

(509) 324-7459 sterling.mcpherson@wsu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

Combining a Smartphone App With Medications to Manage Heavy Drinking

iTBS for Alcohol Use Disorder

Attentional Control Training for Treating Alcohol Use Disorder

Assessing Habitual, Goal-Directed, and Pavlovian Influences in Alcohol Use Disorder

Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer