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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 is a Phase 3 study that has completed, run by Rose Research Center. The registered enrollment target is 180 participants.

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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).

Interventions

  • DRUG Bupropion
  • DRUG Zonisamide
  • OTHER E-cigarette
  • DRUG Placebo bupropion
  • DRUG Placebo zonisamide

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2021-12-14
Est. Completion 2025-10-13
Phase Phase 3

Sponsor

Rose Research Center

11 total trials

What the Registry Record Tells You About NCT05205811

The ClinicalTrials.gov registry entry for NCT05205811 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 180 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 5 interventions - of which Bupropion is the first listed.

NCT05205811 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.