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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
Must not have
Any other current, clinically significant physical disease on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels or direct bilirubin
Current clinically significant blood dyscrasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week treatment and 1-year follow-up period

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.
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.
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
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I am between 18 and 65 years old.
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I am a woman capable of having children, not breastfeeding, using birth control, and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious health issues that could make the study risky for me.
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I have a current serious blood disorder.
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I have a current seizure disorder.
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I have had serious kidney stones or kidney failure.

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

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

Side effects data

From 2009 Phase 3 trial • 64 Patients • NCT00292461
10%
diplopia
7%
dizziness
7%
rash
7%
insomnia
7%
somnolence
3%
pruritus
3%
Abdominal distention
3%
anorexia
3%
contusion
3%
Mood altered
3%
nystagmus
3%
nausia
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
106 Previous Clinical Trials
57,323 Total Patients Enrolled
8 Trials studying Alcoholism
1,411 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
~78 spots leftby Aug 2026
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