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

Last updated: August 9, 2024
Sponsor: Washington State University
Overall Status: Active - Recruiting

Phase

2

Condition

Alcohol Use Disorder

Substance Abuse

Alcohol Dependence

Treatment

Placebo

Zonisamide

Clinical Study ID

NCT05134857
18520-001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 inductionperiod.

  9. Non-lactating women of childbearing age using reliable form of birth control with anegative urine pregnancy test at baseline, and

  10. Attended at least 4 of 6 visits during the induction period.

Exclusion

Exclusion Criteria:

  1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcoholdetoxification or seizure in the last 12 months and expression of concern by theparticipant 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 currentlyfor their seizures, have they ever been told by their provider that they haveepilepsy, 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 ofnormal).

  10. History of traumatic brain injury (TBI; e.g., ever been told by a provider that theyhad a moderate or severe TBI, lost consciousness for 30 minutes or longer or had apost-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, physicalexamination, or routine laboratory evaluation that, in the context of the studywould represent a risk to the subject, or significant laboratory abnormalitiesrelated to hepatic function such as marked elevations of hepatic aminotransferaselevels (i.e., AST and ALT) or direct bilirubin, and

  12. Any other medical or psychiatric condition that Dr. Rodin determines wouldcompromise safe participation.

Study Design

Total Participants: 205
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 07, 2022
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Washington State University

    Spokane, Washington 99202
    United States

    Active - Recruiting

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