The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study (NCT05134857) | Clinical Trial Compass
Active — Not RecruitingPhase 2
The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
United States205 participantsStarted 2022-01-07
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Self Reported Alcohol Consumption
Timeframe: 12-week treatment and 1-year follow-up period
. 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?).