Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

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

Key facts

Study ID

NCT01685996

Run by

Johns Hopkins University

People needed

74

Starts

2012-09-01

Expected to finish

2014-05-01

Last updated by the study team

2018-01-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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