Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05134857

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

Led by Washington State University · Updated on 2024-08-13

205

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Four or more standard drinks on four or more occasions in the prior 30 days.
  • Seeking treatment for alcohol use disorder.
  • Aged 18 to 65 years.
  • Diagnosed with alcohol use disorder according to DSM-5.
  • Ability to read and speak English.
  • Ability to provide written informed consent.
  • Breath alcohol level of 0.00 during informed consent.
  • At least one EtG-positive urine test during the induction period.
  • Non-lactating women of childbearing age using reliable birth control with a negative urine pregnancy test at baseline.
  • Attendance at least 4 of 6 visits during the induction period.
Not Eligible

You will not qualify if you...

  • Significant risk of dangerous alcohol withdrawal, including history of detoxification or seizure in the last 12 months and participant concern.
  • Currently receiving or received pharmacotherapy for alcohol use in the past 30 days.
  • Current diagnosis of severe substance use disorder other than nicotine according to DSM-5.
  • Suicide attempt in the last 20 years.
  • History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy, or allergic reaction to any drug.
  • Presence of systemic autoimmune disease.
  • History of current seizure disorder or epilepsy or recurring seizures in the last 5 years.
  • Current clinically significant blood disorders.
  • History of significant kidney problems, including renal calculi, renal failure, or elevated serum creatinine.
  • History of moderate or severe traumatic brain injury.
  • Any other current significant physical disease or laboratory abnormalities posing risk.
  • Any medical or psychiatric condition deemed unsafe by the study doctor.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Washington State University

Spokane, Washington, United States, 99202

Actively Recruiting

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Research Team

A

Abigail L Bowen, MS

CONTACT

S

Sterling McPherson, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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