A Phase 2 interventional study of Zonisamide and Placebo in Alcohol Use Disorder (AUD), sponsored by Washington State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Washington State University · Phase 2, Interventional, and Treatment
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).
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 205 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Zonisamide (ZON) plus standard treatment (ST)
Drug: Zonisamide
Placebo (PLO) plus standard treatment (ST)
Drug: Placebo
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.
The PLO will be supplied at the same schedule and in the same manner (TAD device) as the ZON.
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).
Time frame: 12-week treatment and 1-year follow-up period
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).
Time frame: 12-week treatment and 1-year follow-up period
Adverse Events
Occurrence of adverse events assessed by SAFETEE (collected 3x weekly at weeks 1-6, 1x weekly at weeks 7-14, and once at weeks 18, 38, and 54).
Time frame: 12-week treatment and 1-year follow-up period
Plan to share: Yes — Data is to be shared with NIAAA under their required data archiving procedures.
Supporting information: Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Washington State University