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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2025
  • participants needed
    205
  • sponsor
    Washington State University
Updated on 25 March 2022
Accepts healthy volunteers

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).

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.

Details
Condition Alcohol Use Disorder (AUD)
Treatment Placebo, zonisamide
Clinical Study IdentifierNCT05134857
SponsorWashington State University
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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