The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

January 7, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Alcohol Use Disorder (AUD)
Interventions
DRUG

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.

DRUG

Placebo

The PLO will be supplied at the same schedule and in the same manner (TAD device) as the ZON.

Trial Locations (1)

99202

RECRUITING

Washington State University, Spokane

All Listed Sponsors
lead

Washington State University

OTHER