Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

NCT00595556 | Completed Phase 4 Results

• 3 other identifiers: 06-113-1P50AA003510M01RR006192
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism; Alcohol Abuse; Alcohol Dependence

Keywords

Zonisamide; Pharmacotherapy; Alcohol dependence; anticonvulsant

Outcome Measures

Primary Outcomes (2)

• Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week

  This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).

  baseline to the end of 12 weeks in treatment

• Weekly Rate of Change in Abstinent Days

  This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).

  baseline to the end of 12 weeks in treatment

Secondary Outcomes (3)

• Change in Number of Drinks Per Week by Week

  baseline to the end of 12 weeks in treatment

• Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)

  baseline to the end of 12 weeks in treatment

• Change in Gamma-glutamyl Transferase (GGT) Concentration

  12 weeks (from initiation to end of treatment)

Study Arms (2)

A

EXPERIMENTAL

Zonisamide

Drug: zonisamide

B

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

zonisamide DRUG

flexible dosages of 100-500mg/day

Also known as: Zonegran

A

Placebo DRUG

Placebo

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The small sample size and the short duration of treatment are limitations. High rates of retention in the treatment and adherence to the medication regimen are strengths. The concomitant psychotherapy may have caused a ceiling effect on medication.

Results Point of Contact

• Title: Albert J. Arias, M.D.
• Organization: UCHC

alarias@uchc.edu

8606794423

Study Officials

• Albert J. Arias, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 6, 2008
• First Posted: January 16, 2008
• Study Start: July 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 15, 2010
• Results First Posted: October 15, 2010

Record last verified: 2010-09

Locations

US (1)