Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized trial to evaluate whether zonisamide can enhance varenicline-induced smoking cessation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine; Varenicline; Zonisamide

Criteria

Inclusion Criteria:

• Ages 18 - 65 years old; smoking > 10 cigarettes per day for > 1 year

• Desire to quit smoking

• Provide a cotinine positive urine sample

• Commitment to come to the clinic once a week for the 10-week study duration

Exclusion Criteria:

• Allergy to varenicline or sulfonamide drugs (e.g., trimethoprim/sulfamethoxazole, zonisamide or topiramate);

• Renal insufficiency (eGFR < 60 mL)

• Renal tubular acidosis

• History of nephrolithiasis

• Unexplained hematuria

• Transaminase elevations > 3 times the Upper Limit of Normal (ULN)

• BMI < 19

• Diabetes mellitus

• Respiratory insufficiency

• Asthma requiring medication

• Heart failure

• Chronic diarrhea predisposing to acidosis

• Glaucoma, family history of glaucoma, one-sided blindness

• History of seizures or use of anticonvulsant medications (not including sedatives)

• HIV infection on HAART medication (or CD4 T cell count < 200 /mL)

• History of serious psychiatric disorder: psychosis, dementia, depression requiring medication in last 6 months, suicidal or homicidal ideation, evidence of violent behavior in the last 6 months.

• Recent use (last 30 days) of bupropion, nortriptyline, or clonidine

• Recent use (last 30 days) of Nicotine Replacement Products that would interfere with urine cotinine testing

• Use of tobacco products other than cigarettes

• For female participants, pregnancy, lactation, or refusal to use an effective method of contraception.