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Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

NCT04388319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-04-13

Study results available
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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

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.

Sponsors & Collaborators

  • Foundation for a Smoke Free World INC

    collaborator OTHER

  • Rose Research Center, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2021-06-04
Completion
2021-09-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388319 on ClinicalTrials.gov