NCT05205811

The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette

A Randomized Controlled Trial to Determine the Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline information on the use of combustible cigarettes. All participants enrolled in the study will receive a JUUL e-cigarette at Visit 2 for ad libitum use. After the first week of e-cigarette use (at Visit 3), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with either zonisamide (100 mg daily) or placebo (group 1 and group 2 respectively), or placebo for both medications (group 3) in addition to continued use of the e-cigarette. At each visit, participants will receive enough study drugs (or placebos) and e-cigarettes to last until their next study visit. The combination of zonisamide and bupropion use will continue until Visit 6 (7 weeks of treatment), and e-cigarette use will continue until the end of treatment (Visit 7).

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Bupropion	Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 7 weeks.
DRUG	Zonisamide	Zonisamide (100 mg/daily) for 7 weeks.
DRUG	Placebo bupropion	Placebo bupropion for 7 weeks.
DRUG	Placebo zonisamide	Placebo zonisamide for 7 weeks.
OTHER	E-cigarette	e-cigarette for ad libitum use for two weeks prior to complete switch day and for an additional 10 weeks.

Timeline

• Start date: 2021-12-14
• Primary completion: 2025-06-19
• Completion: 2025-10-13
• First posted: 2022-01-25
• Last updated: 2026-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study