← Back to Search

Zonisamide for Alcoholism

Phase 2
Recruiting
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-65 years
Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week treatment and 1-year follow-up period
Awards & highlights

Study Summary

This trial will test whether zonisamide can help people with alcohol use disorder drink less alcohol.

Who is the study for?
The ZARRA Study is for adults aged 18-65 with an alcohol use disorder who drink heavily and are seeking treatment. They must be able to read and speak English, consent to the study, have a negative breath alcohol test, provide positive urine tests for alcohol use, and if female and of childbearing age, not be lactating and using birth control. People with severe allergies or recent detox history, other severe substance disorders (except nicotine), significant health issues or taking certain medications can't join.Check my eligibility
What is being tested?
This phase II trial is testing whether zonisamide (ZON) helps reduce alcohol consumption in people wanting to treat their heavy drinking habits. Participants will randomly receive either ZON or a placebo without knowing which one they're getting. The goal is to see if there's a difference in how much they drink while on these treatments.See study design
What are the potential side effects?
While the specific side effects aren't listed here, zonisamide typically may cause drowsiness, dizziness, headache, loss of appetite or weight loss among others. Placebos generally have no active ingredients but can sometimes lead to perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I am a woman capable of having children, not breastfeeding, using birth control, and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-week treatment and 1-year follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-week treatment and 1-year follow-up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Self Reported Alcohol Consumption
Secondary outcome measures
Change in Biochemically Verified Alcohol Consumption
Other outcome measures
Adverse Events

Side effects data

From 2009 Phase 3 trial • 64 Patients • NCT00292461
10%
diplopia
7%
rash
7%
dizziness
7%
insomnia
7%
somnolence
3%
anorexia
3%
Abdominal distention
3%
Mood altered
3%
nystagmus
3%
contusion
3%
nausia
3%
pruritus
3%
Gait disturbance
3%
Lumber contusion
3%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lamotrigine
Zonegran

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZON+STExperimental Treatment1 Intervention
Zonisamide (ZON) plus standard treatment (ST)
Group II: PLO+STPlacebo Group1 Intervention
Placebo (PLO) plus standard treatment (ST)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zonisamide
2006
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,509 Total Patients Enrolled
7 Trials studying Alcoholism
1,286 Patients Enrolled for Alcoholism

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05134857 — Phase 2
Alcoholism Research Study Groups: ZON+ST, PLO+ST
Alcoholism Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05134857 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05134857 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this experiment under 55 years?

"This clinical trial is only open to patients aged between 18 and 65. For those below the age of consent, there are 33 trials available while 255 studies exist for individuals over 65 years old."

Answered by AI

Do I fulfill the criteria necessary to participate in this experiment?

"Successful applicants must have a diagnosis of alcoholism and be within the age range 18-65. This clinical trial is aiming to recruit 205 participants."

Answered by AI

Are additional volunteers being welcomed into this research program?

"A glance at clinicaltrials.gov discloses that this study is currently enrolling patients, with the first post dated July 1st 2022 and the most recent revision made on January 26th 2022."

Answered by AI

Has Zonisamide obtained official authorization from the FDA?

"Due to the lack of evidence regarding efficacy, our team at Power has rated Zonisamide's safety a 2 on its scale. This is because it is currently undergoing Phase 2 trials and data supporting safety exists yet not for effectiveness."

Answered by AI

What is the current number of participants in this research project?

"Affirmative. According to the information published on clinicaltrials.gov, this ongoing medical trial has been accepting applications since January 7th 2022 and was recently updated on January 26th of said year. Presently, 205 applicants are being sought from one location."

Answered by AI

What other research efforts have been conducted regarding Zonisamide?

"At present, there are 6 active clinical trials for zonisamide. None of them have advanced to Phase 3 yet. The majority of the sites running these studies are based in Saint Louis, Missouri; however, research is being conducted at multiple other locations as well."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
Sterling McPherson 2022. "The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05134857.
~73 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top