NCT04388319

Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Zonisamide	Zonisamide (100 mg/daily) for 12 weeks.
DRUG	Bupropion	Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.
OTHER	Halo G6 e-cigarette	G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.

Timeline

• Start date: 2020-05-27
• Primary completion: 2021-06-04
• Completion: 2021-09-15
• First posted: 2020-05-14
• Last updated: 2022-04-13
• Results posted: 2022-03-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study