This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication
zonisamide for the treatment of heavy drinking alcoholic civilians.
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Locations near you
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Full eligibility criteria for NCT02900352
Ages eligible for Study
21 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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
All locations for NCT02900352
United States (4)
University of Connecticut
Farmington, Connecticut, United States, 06030
active not recruiting
New Haven, Connecticut, United States, 06520
West Haven Veterans Affairs
West Haven, Connecticut, United States, 06515
active not recruiting
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Put me in touch!
View full eligibility
Tris trial is registered with FDA with number: NCT02900352. The sponsor of the trial is Virginia Commonwealth University and it is looking for 159 volunteers for the current phase.
Official trial title: Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action
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