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RECRUITING
NCT05134857
PHASE2

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

Sponsor: Washington State University

View on ClinicalTrials.gov

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

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.

Locations (1)

Washington State University

Spokane, Washington, United States