drugset / Trial / NCT04388319

Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

NCT04388319

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2020-05-27
Primary completion
2021-06-04
Completion
2021-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 300 mg
Subject Zonisamide Other / unclassified 100 mg

Indications

No indication recorded.