RECRUITING

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

Conditions

Alcohol Use Disorder (AUD)Alcohol Use Disorder Zonisamide Contingency Management Incentives for Sobriety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-01-07

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05134857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Four or more standard drinks on four or more occasions in the prior 30 days. 2. Seeking AUD treatment. 3. Aged 18-65 years. 4. DSM-5 diagnosis of AUD. 5. Ability to read and speak English. 6. Ability to provide written informed consent. 7. Breath alcohol of 0.00 during informed consent. 8. Provision of at least 1 EtG-positive urine test at any time during the induction period. 9. Non-lactating women of childbearing age using reliable form of birth control with a negative urine pregnancy test at baseline, and 10. Attended at least 4 of 6 visits during the induction period.	1. 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; 2. Currently receiving any pharmacotherapy for alcohol or in the past 30 days. 3. Current DSM-5 diagnosis of severe substance use disorder other than nicotine. 4. Suicide attempt in the last 20 years. 5. History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug 6. Systemic autoimmune disease. 7. 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?). 8. Current clinically significant blood dyscrasia. 9. 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). 10. 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). 11. 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 12. Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.

Inclusion Criteria

Exclusion Criteria

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

1. 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;
2. Currently receiving any pharmacotherapy for alcohol or in the past 30 days.
3. Current DSM-5 diagnosis of severe substance use disorder other than nicotine.
4. Suicide attempt in the last 20 years.
5. History of hypersensitivity to sulfonamide medication, Stevens-Johnson Syndrome, penicillin allergy or allergic reaction to any drug
6. Systemic autoimmune disease.
7. 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?).
8. Current clinically significant blood dyscrasia.
9. 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).
10. 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).
11. 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
12. Any other medical or psychiatric condition that Dr. Rodin determines would compromise safe participation.

Contacts and Locations

Study Contact

Abigail L Bowen, MS

CONTACT

(425) 736-1354

abigail.bowen@wsu.edu

Sterling McPherson, PhD

CONTACT

(509) 324-7459

sterling.mcpherson@wsu.edu

Study Locations (Sites)

Washington State University

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Washington State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-07

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-01-07

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

Alcohol Use Disorder
Zonisamide
Contingency Management
Incentives for Sobriety

Additional Relevant MeSH Terms

Alcohol Use Disorder (AUD)