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NCT05205811 · ClinicalTrials.gov registry record · Phase 3
The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette
A Phase 3 study, sponsored by Rose Research Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
NCT05205811: Completed Phase 3 study, sponsored by Rose Research Center.
NCT05205811 is a Phase 3 study that has completed, run by Rose Research Center. The registered enrollment target is 180 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05205811, a Phase 3 study, has completed, sponsored by Rose Research Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
Study Summary
This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline information on the use of combustible cigarettes. All participants enrolled in the study will receive a JUUL e-cigarette at Visit 2 for ad libitum use. After the first week of e-cigarette use (at Visit 3), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with either zonisamide (100 mg daily) or placebo (group 1 and group 2 respectively), or placebo for both medications (group 3) in addition to continued use of the e-cigarette. At each visit, participants will receive enough study drugs (or placebos) and e-cigarettes to last until their next study visit. The combination of zonisamide and bupropion use will continue until Visit 6 (7 weeks of treatment), and e-cigarette use will continue until the end of treatment (Visit 7).
Primary Outcome
Exhaled carbon monoxide (CO) \< 5 ppm at the end of drug treatment
Interventions
- DRUG Bupropion
- DRUG Zonisamide
- OTHER E-cigarette
- DRUG Placebo bupropion
- DRUG Placebo zonisamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2025-10-13 |
| Phase | Phase 3 |
What the finished NCT05205811 record still lists
NCT05205811 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Bupropion is the first listed.
NCT05205811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05205811 about?
NCT05205811 is a clinical study titled "The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette". This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline ...
What is the current status of trial NCT05205811?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2021-12-14. Estimated completion is 2025-10-13.
What interventions are being tested in trial NCT05205811?
The interventions under investigation include: Bupropion (DRUG), Zonisamide (DRUG), E-cigarette (OTHER), Placebo bupropion (DRUG), Placebo zonisamide (DRUG).
Who is sponsoring clinical trial NCT05205811?
This trial is sponsored by Rose Research Center, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05205811's enrollment target sits among peer trials
180 1422nd of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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