Phase
Condition
Alcohol Use Disorder
Substance Abuse
Alcohol Dependence
Treatment
Placebo
Zonisamide
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 inductionperiod.
Non-lactating women of childbearing age using reliable form of birth control with anegative urine pregnancy test at baseline, and
Attended at least 4 of 6 visits during the induction period.
Exclusion
Exclusion Criteria:
Significant risk of dangerous alcohol withdrawal, defined as a history of alcoholdetoxification or seizure in the last 12 months and expression of concern by theparticipant 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 currentlyfor their seizures, have they ever been told by their provider that they haveepilepsy, 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 ofnormal).
History of traumatic brain injury (TBI; e.g., ever been told by a provider that theyhad a moderate or severe TBI, lost consciousness for 30 minutes or longer or had apost-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, physicalexamination, or routine laboratory evaluation that, in the context of the studywould represent a risk to the subject, or significant laboratory abnormalitiesrelated to hepatic function such as marked elevations of hepatic aminotransferaselevels (i.e., AST and ALT) or direct bilirubin, and
Any other medical or psychiatric condition that Dr. Rodin determines wouldcompromise safe participation.
Study Design
Study Description
Connect with a study center
Washington State University
Spokane, Washington 99202
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.