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

NCT05134857 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 18520-001
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorder; Zonisamide; Contingency Management; Incentives for Sobriety

Outcome Measures

Primary Outcomes (1)

• 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).

  12-week treatment and 1-year follow-up period

Secondary Outcomes (1)

• Change in Biochemically Verified Alcohol Consumption

  12-week treatment and 1-year follow-up period

Other Outcomes (1)

• Adverse Events

  12-week treatment and 1-year follow-up period

Study Arms (2)

ZON+ST

EXPERIMENTAL

Zonisamide (ZON) plus standard treatment (ST)

Drug: Zonisamide

PLO+ST

PLACEBO COMPARATOR

Placebo (PLO) plus standard treatment (ST)

Drug: Placebo

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.

ZON+ST

Placebo DRUG

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

PLO+ST

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Four or more standard drinks on four or more occasions in the prior 30 days.
• Seeking AUD treatment.
• Aged 18-65 years.
• DSM-5 diagnosis of AUD.
• Ability to read and speak English.
• Ability to provide written informed consent.
• Breath alcohol of 0.00 during informed consent.
• Provision of at least 1 EtG-positive urine test at any time during the induction period.
• Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and
• Attended at least 4 of 6 visits during the induction period.

You may not qualify if:

• Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal;
• Currently receiving any pharmacotherapy for alcohol or in the past 30 days.
• Current DSM-5 diagnosis of severe substance use disorder other than nicotine.
• Suicide attempt in the last 20 years.
• History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
• Systemic autoimmune disease.
• History of current seizure disorder (e.g., are they receiving medication currently for their seizures, have they ever been told by their provider that they have epilepsy, or do they have a history of recurring seizures in the last 5 years?).
• Current clinically significant blood dyscrasia.
• History of clinically significant renal calculi or renal failure; renal compromise (defined by an elevation of serum creatinine above our laboratory's limit of normal).
• History of traumatic brain injury (TBI; e.g., ever been told by a provider that they had a moderate or severe TBI, lost consciousness for 30 minutes or longer or had a post-traumatic amnesia lasting a day or longer).
• Any other current, clinically significant physical disease \[i.e., neurologic, renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine, cardiovascular, hepatic, or autoimmune disease\] on the basis of medical history, physical examination, or routine laboratory evaluation that, in the context of the study would represent a risk to the subject, or significant laboratory abnormalities related to hepatic function such as marked elevations of hepatic aminotransferase levels (i.e., AST and ALT) or direct bilirubin, and
• Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Abigail L Bowen, MS

CONTACT

(425) 736-1354; abigail.bowen@wsu.edu

Sterling McPherson, PhD

CONTACT

(509) 324-7459; sterling.mcpherson@wsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A phase II randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 26, 2021
• Study Start: January 7, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 5-6 years
• Access Criteria: Determined by NIAAA data archive policy

Locations

US (1)