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The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
Sponsor: Washington State University
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).
Official title: Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
205
Start Date
2022-01-07
Completion Date
2026-08-31
Last Updated
2024-08-13
Healthy Volunteers
Yes
Conditions
Interventions
Zonisamide
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.
Placebo
The PLO will be supplied at the same schedule and in the same manner (TAD device) as the ZON.
Locations (1)
Washington State University
Spokane, Washington, United States