At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
In Brief
A Phase 3 clinical trial evaluating Zonisamide, Bupropion, and 1 other intervention for Smoking Cessation. Completed, enrolled 26 participants across 2 sites.
Detailed Summary
This single-group, small-scale, open-label study (N= 25 to 50) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CC) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline data on use of combustible cigarettes. Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants will be given zonisamide (100 mg/daily) and will begin extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) in addition to continued use of the G6. At each visit, participants will receive enough zonisamide, bupropion, and Halo G6 cartomizers to last until their next study visit. Halo G6 and combination zonisamide and bupropion use will continue until the participant returns for the End-of-Study visit (V7).
Study Details
Timeline
Interventions
Zonisamide (100 mg/daily) for 12 weeks.
Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.
G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.