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New pill helps smokers kick the habit in major trial

NCT ID NCT04576949

Disease control Sponsor: Achieve Life Sciences Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a pill called cytisinicline to help adults stop smoking. Over 800 daily smokers took the pill or a placebo for 6 or 12 weeks. The goal was to see if the pill helped them stay smoke-free, verified by breath tests. Results showed it was effective for quitting smoking.

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

810 people

The number who actually took part.

Started

Oct 2020

Finished

Dec 2021

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. Current daily cigarette smokers (averaging at least 10 cigarettes per day upon completing a 7-day screening smoking diary) and who intend to quit smoking. 3. Expired air carbon monoxide (CO) ≥10 ppm. 4. Failed at least one previous attempt to stop smoking with or without therapeutic support. 5. Willing to initiate study treatment on the day after randomization and set a quit date within 5-7 days of starting treatment. 6. Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study. 7. Able to fully understand study requirements, willing to participate, and comply with dosing schedule. 8. Sign the Informed Consent Form. Exclusion Criteria: 1. More than 1 study participant in same household. 2. Previous cytisinicline treatment in a prior clinical study or any other cytisine usage. 3. Known hypersensitivity to cytisinicline or any of the excipients. 4. Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisinicline. 5. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (ie, requiring treatment or monitoring). 6. Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (ie, requiring treatment or further assessment). 7. Body mass index (BMI) classification for being underweight (\<18.5 kg/m\^2) or having ≥Class 2 obesity (≥35 kg/m\^2). 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. 11. Currently having suicidal ideation or risk for suicide ("Yes" to question 4 or question 5 OR "Yes" to any suicidal behavior question on the Columbia - Suicide Severity Rating Scale \[C-SSRS\]). 12. Current symptoms of moderate to severe depression (Hospital Anxiety and Depression Scale\[HADS\] score ≥11). 13. Renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min (estimated with the Cockroft-Gault equation). 14. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN). 15. Women who are pregnant or breast-feeding. 16. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period. 17. Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization. 18. Treatment with other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy \[NRT\]) in the 4 weeks prior to randomization or planned use of these other smoking cessation medications during the study. 19. Use within the 2 weeks prior to randomization or planned use during the study of non-cigarette and/or noncombustible nicotine products (pipe tobacco, cigars, snuff, smokeless tobacco, hookah, e-cigarettes/vaping) or marijuana smoking or vaping. 20. 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.

Smoking Cessation

As listed by the trial registrant

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

Smoking cessation

Contacts and locations

Locations

  • AMR Lexington

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134, United States

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207, United States

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119, United States

  • Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119, United States

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502, United States

  • Alliance for Multispecialty Research, LLC.

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research, LLC.

    Knoxville, Tennessee, 37920, United States

  • Arizona State University

    Phoenix, Arizona, 85044, United States

  • Clinical Research Atlanta

    Atlanta, Georgia, 30281, United States

  • Coastal Carolina Research Center, Inc.

    Mt. Pleasant, South Carolina, 29464, United States

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231, United States

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612, United States

  • Massachusetts General Hospital - Clinical Genetic Research Facility

    Boston, Massachusetts, 02114, United States

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714, United States

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609, United States

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