Phase 2
Completed N=74
Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
Source: ClinicalTrials.gov NCT01685996 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Percent Participants Abstinent From Smoking During Study Weeks 7-10 — 5; 6 Participants
Summary
Randomized trial to evaluate whether zonisamide can enhance varenicline-induced smoking cessation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Participants Abstinent From Smoking During Study Weeks 7-10 |
5; 6 | — |
| SECONDARY Nicotine Withdrawal Symptom Severity |
4.6; 5.6; 5.1; 7.0; 5.3; 6.2 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT01685996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.