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

Part of paid clinical trials in Spokane, Washington.

Sponsor
Washington State University
Study ID
NCT05134857
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jan 7, 2022
Status verified
Aug 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
205 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ZON+ST
    Zonisamide (ZON) plus standard treatment (ST)
  • Placebo Comparator: PLO+ST
    Placebo (PLO) plus standard treatment (ST)

Primary Outcome Measure

Change in Self Reported Alcohol Consumption [ Time Frame: 12-week treatment and 1-year follow-up period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington State UniversitySpokaneWashington99202
Abigail L Bowen, MS
[email protected]
425-736-1354
Serena McPherson, BA
[email protected]
(509) 590-7689

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