Alcohol Use Disorder (AUD)Phase 2NCT05134857
The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
A Phase 2 study testing Zonisamide in people with Alcohol Use Disorder (AUD), run by Washington State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Zonisamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Breath alcohol of 0.00 during informed consent.
- Provision of at least 1 EtG-positive urine test at any time during the induction period.
- Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and
- Attended at least 4 of 6 visits during the induction period.
Who cannot join
- 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.
- Suicide attempt in the last 20 years.
- History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
- Systemic autoimmune disease.
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- 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?).
- Current clinically significant blood dyscrasia.
- History of clinically significant renal calculi or renal failure; renal compromise (defined by an elevation of serum creatinine above our laboratory's limit of normal).
- History of traumatic brain injury (TBI; e.g., ever been told by a provider that they had a moderate or severe TBI, lost consciousness for 30 minutes or longer or had a post-traumatic amnesia lasting a day or longer).
- Any other current, clinically significant physical disease [i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune 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 (i.e., AST and ALT) or direct bilirubin, and
- Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99202
About this study
Official title: Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework
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).
Read the detailed description
This project focuses on the efficacy of a promising pharmacotherapy (ZON) for AUDs using a placebo-controlled design that will rigorously measure alcohol use and medication adherence. Results will guide novel mechanistic targets to better capture the heterogeneity within AUDs. This project will evaluate the ability of ZON to treat the alcohol use disorder.
The investigators hypothesize that the group assigned to ZON associated with the standard treatment (ZON+ST) will yield lower rates of biochemically verified alcohol use, fewer self-reported drinks per day, and fewer heavy drinking days during the 12-week treatment and 1-year follow-up periods, relative to the placebo associated with the standard treatment (PLO+ST) group.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Zonisamide, Placebo
- Keywords
- Alcohol Use Disorder, Zonisamide, Contingency Management, Incentives for Sobriety
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
The ZON will be supplied in 100 mg capsules and deposited directly into the TAD device by research staff every 2 weeks. All participants will be told to take 100 mg/day for the first three weeks (Week 1-2 single-blind, placebo-only, induction; end of Week 2, active treatment begins) and increasing by 100 mg/day every other week (Week 4: 200 mg/day; Week 6: 300 mg/day; Week 8: 400 mg/day) up to the target dose of 500 mg/day by Week 10. The participants will be maintained on this dose through Week 14 of active treatment and then tapered off ZON (2 weeks). This dosing schedule is consistent with best practices for ZON. All TAD devices will only dispense the prescribed medication between 4pm and 11pm each night. Participants will be instructed to take the medication at or near bedtime.
PlaceboDrug
The PLO will be supplied at the same schedule and in the same manner (TAD device) as the ZON.
| Study group | Role | What they receive |
|---|---|---|
| ZON+ST | Experimental | Zonisamide (ZON) plus standard treatment (ST) Receives: Drug: Zonisamide |
| PLO+ST | Placebo comparator | Placebo (PLO) plus standard treatment (ST) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self Reported Alcohol Consumption
Consumption of alcohol between participants randomized to ZON+ST vs PLO+ST assessed by participant self report (collected 1x weekly from weeks 1-14 and once at weeks 18, 38, and 54).
Measured: 12-week treatment and 1-year follow-up period
Secondary outcomes (1)
Change in Biochemically Verified Alcohol Consumption
Consumption of alcohol between participants randomized to ZON+ST vs PLO+ST assessed by alcohol breathalyzer and biochemical EtG values (collected 3x weekly from weeks 1-6, 1x weekly at weeks 7-14, and once at weeks 18, 38, and 54).
Measured: 12-week treatment and 1-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start7 Jan 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase II randomized, double-blind, placebo-controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sterling McPherson, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134857
- Sponsor's protocol ID
- 18520-001
- Status last verified
- Jul 2026
- First submitted
- 14 Oct 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is to be shared with NIAAA under their required data archiving procedures.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework
- ClinicalTrials.gov ID
- NCT05134857
- Acronym / sponsor ID
- 18520-001
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Use Disorder, Zonisamide, Contingency Management, Incentives for Sobriety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This project focuses on the efficacy of a promising pharmacotherapy (ZON) for AUDs using a placebo-controlled design that will rigorously measure alcohol use and medication adherence. Results will guide novel mechanistic targets to better capture the heterogeneity within AUDs. This project will evaluate the ability of ZON to treat the alcohol use disorder.
The investigators hypothesize that the group assigned to ZON associated with the standard treatment (ZON+ST) will yield lower rates of biochemically verified alcohol use, fewer self-reported drinks per day, and fewer heavy drinking days during the 12-week treatment and 1-year follow-up periods, relative to the placebo associated with the standard treatment (PLO+ST) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A phase II randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| ZON+ST | Experimental | Drug: ZonisamideZonisamide (ZON) plus standard treatment (ST) |
| PLO+ST | Placebo comparator | Drug: PlaceboPlacebo (PLO) plus standard treatment (ST) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Suicide attempt in the last 20 years.
- History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZonisamideThe ZON will be supplied in 100 mg capsules and deposited directly into the TAD device by research staff every 2 weeks. All participants will be told to take 100 mg/day for the first three weeks (Week 1-2 single-blind, placebo-only, induction; end of Week 2, active treatment begins) and increasing by 100 mg/day every other week (Week 4: 200 mg/day; Week 6: 300 mg/day; Week 8: 400 mg/day) up to the target dose of 500 mg/day by Week 10. The participants will be maintained on this dose through Week 14 of active treatment and then tapered off ZON (2 weeks). This dosing schedule is consistent with best practices for ZON. All TAD devices will only dispense the prescribed medication between 4pm and 11pm each night. Participants will be instructed to take the medication at or near bedtime. | Drug | ZON+ST |
| PlaceboThe PLO will be supplied at the same schedule and in the same manner (TAD device) as the ZON. | Drug | PLO+ST |
Primary outcome
Change in Self Reported Alcohol Consumption
Time frame: 12-week treatment and 1-year follow-up period
Consumption of alcohol between participants randomized to ZON+ST vs PLO+ST assessed by participant self report (collected 1x weekly from weeks 1-14 and once at weeks 18, 38, and 54).
1 secondary outcome
Change in Biochemically Verified Alcohol Consumption
Time frame: 12-week treatment and 1-year follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Data is to be shared with NIAAA under their required data archiving procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zonisamide in people with Alcohol Use Disorder (AUD), run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self Reported Alcohol Consumption (time frame: 12-week treatment and 1-year follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.