Overview

Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

Status:
Completed
Trial end date:
2021-04-22
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Virginia Commonwealth University
Yale University
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Connecticut
VA Connecticut Healthcare System
Yale University
Treatments:
Ethanol
Zonisamide
Criteria
Inclusion Criteria:

- Female/male aged 21-70 years

- Regular heavy drinkers as defined by averaging 2 heavy drinking days per week over 90
days baseline pre-treatment timeline follow-back (TLFB), and current DSM-IV-TR alcohol
dependence that recognize a need to reduce or stop drinking (Note: heavy drinking days
will be defined as follows; for men greater than or equal to 5 drinks in a day and for
women greater than or equal to 4 drinks in a day)

- Women of child-bearing potential (i.e., no hysterectomy, bilateral oophorectomy, or
tubal ligation or <2 years postmenopausal), must be non-lactating, practicing a
reliable method of birth control, and have a negative serum pregnancy test prior to
initiation of treatment;

- Willingness to provide signed, informed consent to participate in the study

Exclusion Criteria:

- A current, clinically significant physical disease or abnormality (i.e., neurologic,
renal, rheumatologic, gastrointestinal, hematologic, pulmonary, endocrine,
cardiovascular, hepatic, or autoimmune disease that, in the context of the study would
represent a risk to the subject, or significant laboratory abnormalities such as
hepatic aminotransferase levels (i.e., AST and ALT) greater than 300% of the upper
limit of normal or direct bilirubin levels >150% of the upper limit of normal) on the
basis of medical history, physical examination, or routine laboratory evaluation.
Other specific exclusionary disorders include;

- History of clinically significant renal calculi or renal failure; a significant
indication of renal compromise will be defined by an elevation of serum creatinine
above the investigators' laboratory's limit of normal, or a known history of renal
failure or chronic renal disease, or any current or chronic disease that could
reasonably be expected to result in renal failure

- History of hypersensitivity to ZNS or any sulfonamide, Stevens-Johnson Syndrome,
penicillin allergy, or history of any severe drug allergic reaction; History of
systemic autoimmune disease such as lupus erythematosis, fibromyalgia, or rheumatoid
arthritis;

- Current blood dyscrasia or a history of such, with the exception of a past history of
iron deficiency anemia

- History of seizure disorder

- Use of any of a number of medications that might prominently influence drinking
patterns or cause risk of harm or injury (e.g., topiramate, disulfiram, naltrexone,
acetazolamide, stimulants such as amphetamine, or tramadol; Schizophrenia, bipolar
disorder, PTSD, or substantial suicide or violence risk (i.e., can't be managed safely
in the outpatient setting) on the basis of history or psychiatric examination; j)
currently dependent on opioids or benzodiazepines or other sedatives

- Considered by the investigators to be clinically inappropriate for study participation
or have participated in another pharmacotherapy study in the past thirty days

- Subjects with prominent signs of physical dependence, and/or medical comorbidities
such that study physicians feel they should consider immediate detoxification, and
referred for medical detoxification in a normal treatment setting