Can a natural compound help kick the vaping habit?
NCT ID NCT05431387
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a pill called cytisinicline, made from a plant compound, to see if it helps adults stop using nicotine e-cigarettes. 160 daily vapers took either the drug or a placebo for 12 weeks, along with brief counseling. The main goal was to see if more people could quit vaping for at least 4 weeks by the end of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cytisinicline (also known as cytisine) – a plant-based tablet to reduce nicotine cravings
- What this could lead to
- If successful, this could provide a new medication option to help people quit vaping, similar to how it is used for smoking cessation.
- What could go wrong
- This is a small Phase 2 trial with only 160 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are possible.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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160 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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Feb 2023
- 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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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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. Male or female subjects, age ≥ 18 years. 2. Test positive for cotinine using the Alere iScreen® OFD Cotinine Oral Fluid Screening Device (Positive testing at ≥ 30 ng/mL cotinine level). 3. Current daily nicotine-containing electronic cigarette usage as recorded in a screening diary for at least 7 consecutive days. Willing to bring the e-cigarette or nicotine device used to the clinical site so that the specific product type, flavor, and nicotine level can be documented. 4. Willing to initiate study treatment on the day after randomization and set a quit date within 7-14 days of starting treatment. 5. Willing to actively participate in the study's vaping cessation behavioral support provided throughout the study. 6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule. 7. Sign the Informed Consent Form. Exclusion Criteria: 1. Currently smoking, or having smoked within 4 weeks prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products (such as heat not burn products) (i.e., dual users). 2. Expired carbon monoxide (CO) levels ≥ 10 ppm, indicating recent combustible tobacco use. 3. More than 1 study participant in same household during the study treatment period. 4. Known hypersensitivity to cytisinicline or any of the excipients. 5. Positive urinary drugs of abuse screen determined within 28 days before the first dose of cytisinicline (Note: tetrahydrocannabinol (THC) is not part of the abuse screen). 6. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e., requiring treatment or monitoring). 7. Clinically significant abnormalities in 12-lead electrocardiogram determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e., requiring treatment or further assessment). 8. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure. 9. Current uncontrolled hypertension (blood pressure ≥ 160/100 mmHg). 10. Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic; having suicidal ideation within the last 3 months (corresponding to question 4 or 5 on the Columbia - Suicide Severity Rating Scale \[C-SSRS\]); or current symptoms of moderate to severe depression (depression score ≥ 11 on the HADS) within the last 3 months. 11. Renal impairment defined as a creatinine clearance (CrCl) \< 60 mL/min (estimated with the Cockroft-Gault equation). 12. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.0 x the upper limit of normal (ULN). 13. Recent history or symptoms (within 4 weeks of randomization) of unstable respiratory disease (e.g., pneumonia, product-use associated lung injury or e-cigarette or vaping use-associated lung injury \[EVALI\], etc.) 14. Women who are pregnant or breast-feeding. 15. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control starting at the time of consent, during the study treatment period, and continuing for one month after ending study treatment. 16. Participation in a clinical study with an investigational drug in the 4 weeks prior to study randomization. 17. Use of other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy \[NRT\]) in the 4 weeks prior to study randomization, any previous cytisinicline use, or planned use of these or other nicotine replacement medications during the study. 18. Any planned use during the study of combustible cigarettes or other nicotine-containing, non-vaping products (e.g., pipe tobacco, cigars, snuff, smokeless tobacco, hookah, ZYN pouches, etc). 19. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
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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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Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509, United States
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Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920, United States
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Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
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Massachusetts General Hospital - Clinical Genetic Research Facility
Boston, Massachusetts, 02114, United States
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Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
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