Effectiveness of Zonisamide in Alcohol Dependent Veterans

NCT02368431 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CLNA-003-14SICX001012A
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic Veterans.

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Alcoholism; Alcohol Dependence; Zonisamide; Alcoholic Intoxication; Drinking Behaviors; Anticonvulsants

Outcome Measures

Primary Outcomes (1)

• Number of Drinks Per Week

  Difference between groups in the number of total standard drinks per week over 8 weeks (weeks 9-16, the weeks on the target dose) performed using a mixed models longitudinal analysis.

  over 8 weeks (weeks 9-16)

Secondary Outcomes (6)

• Percentage of Subjects With No Heavy Drinking Days (PSNHDD)

  Baseline

• Gamma Glutamyl Transferase (GGT)

  Baseline, Week 4, 8 and 16

• Number of Heavy Drinking Days Per Week

  over 16 weeks (weeks 1-16)

• Alcohol Urge Questionnaire Score (AUQ)

  over 16 weeks (weeks 1-16)

• Change in Quality of Life

  Over 16 weeks (Baseline and 16 weeks)

Study Arms (2)

Zonisamide

EXPERIMENTAL

Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind (Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose). Subjects may increase their dose to 600mg daily during the target treatment period if it is thought to be beneficial.

Drug: Zonisamide

Placebo

PLACEBO COMPARATOR

Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group)

Drug: Placebo

Interventions

Zonisamide DRUG

Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose

Also known as: Zonegran

Zonisamide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female/male veterans 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 alcohol dependence diagnosis by the Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) 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

You may not qualify if:

• History of 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 zonisamide 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, posttraumatic stress 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcoholic Intoxication; Drinking Behavior

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Albert Arias
• Organization: VA Connecticut Healthcare System West Haven Campus, West Haven, CT

albert.arias@vcuhealth.org

804-828-5793

Study Officials

• Albert J Arias, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2015
• First Posted: February 23, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 7, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)