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Can a drug combo help smokers ditch cigarettes for E-Cigs?
NCT ID NCT05205811
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
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Dec 2021
- Finished
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Oct 2025
- Lead sponsor
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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
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rose Research Center
Charlotte, North Carolina, 28262, United States
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Rose Research Center
Raleigh, North Carolina, 27617, United States
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