Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

NCT ID: NCT00595556

Last Updated: 2010-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-05-31

Brief Summary

This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.

Detailed Description

Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism.

This is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.

Conditions

Alcoholism; Alcohol Abuse; Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Zonisamide

Group Type: EXPERIMENTAL

zonisamide

Intervention Type: DRUG

flexible dosages of 100-500mg/day

B

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

zonisamide

flexible dosages of 100-500mg/day

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Zonegran

Eligibility Criteria

Inclusion Criteria

• age 18 to 65 years, inclusive
• current Diagnostic & Statistical Manual of Mental Disorders 4th ed (DSM-IV) alcohol dependence (within the past month)
• have 2 heavy drinking days per week during the period between screening and baseline (defined as >4 standard drinks per day for males, and >3 standard drinks per day for females)
• able to read at the eighth grade or higher level and show no evidence of significant cognitive impairment
• if a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or who is less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control including barrier method; and have a negative serum pregnancy test prior to initiation of treatment
• be willing to provide signed, informed consent to participate in the study

Exclusion Criteria

• have 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 greater than 300% of the uper limit of normal or direct bilirubin levels 150% of the upper limit of normal) on the basis of medical history, physician examination, or routine laboratory evaluation. Serum creatinine level of > 1.2 mg/dl will also be exclusionary. Other specific exclusionary disorders include:

• patients with a history of renal calculi
• patients with a history of hypersensitivity to zonisamide or any sulfonamide, Stevens-Johnson Syndrome, penicillin allergy, or history of any severe drug allergic reaction
• patients with a significant history of systemic autoimmune disease such as lupus erythematosis, fibromyalgia, or rheumatoid arthritis
• patients with a current blood dyscrasia or a history of such, with the exception of a remote history of iron deficient anemia
• have a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, or substantial suicide or violence risk) on the basis of history or psychiatric examination
• current dependence on opioids or benzodiazepines or other sedatives will also be exclusionary
• are considered by investigators to be clinically inappropriate for study participation
• because individuals with a history of seizure disorder could potentially be at increased risk of experiencing a seizure due to their drinking, such individuals will also be excluded
• have participated in another pharmacotherapy study in the past thirty days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

University of Connecticut Health Center

Principal Investigators

Albert J. Arias, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

P50AA003510

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M01RR006192

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-113-1

Identifier Type: -

Identifier Source: org_study_id