The Effects of Zonisamide on Alcohol Dependence
Information source: Boston University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism
Intervention: Zonisamide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Boston University Official(s) and/or principal investigator(s): Clifford Knapp, PhD, Principal Investigator, Affiliation: Boston University
Summary
In this study the influence of zonisamide administration over a 13 week period on alcohol
consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of
zonisamide given to subjects will be slowly increased over a period of several weeks. They
will receive a full dose over a 5 week period. This will be a pilot study in which all of
the subjects will only receive zonisamide. A primary objective of this study is to determine
the possible size of the effect that zonisamide administration has on drinking (i. e. drinks
consumed per day) to allow us to plan for a larger clinical trial of the effects of
zonisamide on alcohol dependence.
Clinical Details
Official title: The Effects of Zonisamide on Alcohol Dependence
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment PhaseDifference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).
Secondary outcome: Symbol Digit Modalities Test (DSMT)
Eligibility
Minimum age: 21 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA
To be admitted into this study patients must meet the following criteria:
1. DSM IV TR Diagnosis of Alcohol Dependence; minimal level of 14 drinks per week for
women or 21 drinks per week for men over a 28 day consecutive period during the 90
day period prior to the screening session.
2. Male or Female 21-64 years of age.
3. Able to provide informed consent and comprehend study procedures.
4. Negative urine toxicological screen for opioids, psychomotor stimulants,
sedative-hypnotics, and cannabinoids. If the urine tox screen was positive for any
substance it may be repeated within two weeks.
5. Score of >8 on the Alcohol Use Disorder Identification Test (AUDIT) during screening.
6. Must be suitable for outpatient management of alcoholism.
7. Express desire to stop drinking or reduce alcohol consumption with a possible
long-term goal of abstinence.
8. Provide contact information for themselves or an alternate contact that the staff
will call in case of missed appointment.
9. Women must be postmenopausal for at least one year, be surgically sterile, be using
an effective method of birth control (e. g. contraceptive injection, intrauterine
device, spermicide with barrier, contraceptive patch, contraceptive ring, male
partner sterilization, oral contraceptives) or completely abstinent (and agree to use
one of the above mentioned methods of contraception if sexual activity is ever
initiated).
10. Must be able to take oral medications, adhere to the regimen and be willing to return
for follow up visits.
11. Must have breath alcohol concentration of no more than 0. 01% when the informed
consent is provided and the consent form is signed.
12. Must have resided at the same address for at least 3 months.
EXCLUSION CRITERIA
Patients meeting the following criteria will be excluded from the study:
1. Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine,
or caffeine.
2. DSM IV-TR diagnosis of any current Axis I diagnosis other than alcohol dependence,
nicotine dependence, or caffeine dependence that in the opinion of the study
physicians might require intervention with either pharmacological or
non-pharmacological therapy that will interfere with the course of the study.
3. Receiving inpatient or outpatient treatment for alcohol dependence (with the
exception of AA or other self-help groups) within 4 weeks prior to enrollment into
this study.
4. Subjects with a score of 10 or greater on the CIWA-Ar (a withdrawal scale) on first
or second visits.
5. Currently being treated with acamprosate, disulfiram or naltrexone.
6. Currently being treated with any of the following medications: a) Antipsychotic
agents- including clozapine, risperidone, quetiapine, haloperidol b) Antimanic or
anticonvulsant agents- including lithium carbonate, phenytoin, phenobarbital,
carbamazepine, topiramate, valproic acid, divalproex, tiagabine c) Sedative-hypnotic
or antianxiety agents-including triazolam, temazepam, zolpidem, zalepron, buspirone,
alprazolam, diazepam, clonazepam, oxazepam, lorazepam d) chronic opioid treatment-
including methadone, buprenorphine, oxycodone, morphine e) Psychomotor stimulants-
amphetamine derivatives, methylphenidate
7. Subjects who are legally mandated to participate in an alcohol treatment program
8. Use of any medication known to inhibit or induce cytochrome P450 3A4 enzymes
including macrolide antibiotics, fluoxetine, and carbamazepine.
9. Subjects who have attempted suicide or who have had suicidal ideation within 30 days
of their first visit as assessed using responses from the SCID and Hamilton
Depression scale.
10. Subjects with renal disease (including severe infection and cancer), impaired renal
clearance (CrCl less than 50 ml/min), or history of kidney stones.
11. Subjects with AST or ALT >3 times the upper limit of the normal range during
screening.
12. History of significant neurological disorder, including a history of seizures,
stroke, dementia, multiple sclerosis, Parkinson's disease, brain tumors, or
encephalitis.
13. Subjects who are pregnant (as assessed by serum HCG) or lactating.
14. Subjects known to have clinically significant medical conditions. These may include:
symptomatic CAD or PVD, malignancy or history of malignancy in the last 5 years,
significant pulmonary disease or endocrinological disorders.
15. Subjects with prior hypersensitivity to zonisamide or related compounds, including
sulfonamides (e. g. sulfisoxazole) carbonic anhydrase inhibitors (e. g. acetazolamide),
sulfonylureas (e. g. chlorpropamide), sulfamates (e. g. topiramate), thiazide (e. g.
hydrochlorothiazide), and loop diuretics (e. g. furosemide) except ethacrycrynic acid.
16. Subjects who in the opinion of the study physicians should not be enrolled based on
the precautions, warnings, and contraindications stated on the package insert for
zonisamide.
17. Impending incarceration.
18. Score of 25 or less on the Folstein Mini-Mental examination.
19. History of anticonvulsant-induced rash.
Locations and Contacts
Boston University School of Medicine, Boston, Massachusetts 02118, United States
Additional Information
Starting date: November 2006
Last updated: May 6, 2010
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