Actively Recruiting
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
Eligibility Criteria
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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington State University
Spokane, Washington, United States, 99202
Actively Recruiting
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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