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Can a drug combo help smokers ditch cigarettes for E-Cigs?

NCT ID NCT05205811

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking zonisamide and bupropion together helps smokers switch completely to an e-cigarette (JUUL). 180 adult smokers who wanted to switch were given the drugs or placebos for 7 weeks while using the e-cigarette. The goal was to see if the combination made it easier to stop smoking regular cigarettes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zonisamide and bupropion (drugs)
What this could lead to
If it works, this could point toward a new medication combination to help smokers switch to less harmful e-cigarettes.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The study only tested switching to a specific e-cigarette, so findings may not apply to all smokers or devices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

180 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Has signed the ICF and is able to read and understand the information provided in the ICF. 2. Is 21 to 65 years of age (inclusive) at screening. 3. Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months. 4. Has an expired air CO reading of at least 10 ppm at screening. 5. Is interested in switching to an electronic cigarette. 6. Is willing and able to comply with the requirements of the study. 7. Owns a smartphone with text message and data capabilities compatible with necessary surveys. Exclusion Criteria: 1. Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history). 2. Has a PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening. 3. Has plans to use an FDA-approved smoking cessation product during the study. 4. Has high blood pressure (systolic \> 150 mmHg or diastolic \>95 mmHg) at screening. 5. Has body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2. 6. Has coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure. 7. Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study. 8. Is taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc. 9. Has used any of these products in the past 30 days: 1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates); 2. Experimental (investigational) drugs that are unknown to participant; 3. Chronic opiate use. 10. Has used smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black \& Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening. 11. Has a plan to use an FDA-approved quit-smoking treatment in the next 30 days. 12. Is pregnant or nursing (by self-report) or has a positive pregnancy test. 13. Enrollment requirements met.

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Conditions

The condition(s) this trial relates to.

Smoking Cessation Vaping

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Rose Research Center

    Charlotte, North Carolina, 28262, United States

  • Rose Research Center

    Raleigh, North Carolina, 27617, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.