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NCT04388319 · ClinicalTrials.gov registry record · Phase 3
Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
A Phase 3 study, sponsored by Rose Research Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT04388319 is a Phase 3 study that has completed, run by Rose Research Center. The registered enrollment target is 26 participants.
The verdict
NCT04388319, a Phase 3 study, has completed, sponsored by Rose Research Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study 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).
Interventions
- DRUG Bupropion
- DRUG Zonisamide
- OTHER Halo G6 e-cigarette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2021-09-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04388319
The ClinicalTrials.gov registry entry for NCT04388319 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rose Research Center, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bupropion is the first listed.
NCT04388319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04388319 about?
NCT04388319 is a clinical study titled "Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes". 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 ...
What is the current status of trial NCT04388319?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2020-05-27. Estimated completion is 2021-09-15.
What interventions are being tested in trial NCT04388319?
The interventions under investigation include: Bupropion (DRUG), Zonisamide (DRUG), Halo G6 e-cigarette (OTHER).
Who is sponsoring clinical trial NCT04388319?
This trial is sponsored by Rose Research Center, which has 11 total clinical trials registered on ClinicalTrials.gov.
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