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Can a natural compound help kick the vaping habit?

NCT ID NCT05431387

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

160 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2023

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Massachusetts General Hospital - Clinical Genetic Research Facility

    Boston, Massachusetts, 02114, United States

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609, United States

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