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New pill shows promise for Long-Term smoking and vaping cessation

NCT ID NCT06435221

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 study tested the long-term safety of cytisinicline, a plant-based pill, taken three times daily for 52 weeks by 479 adults who previously took part in smoking or vaping cessation trials. The main goal was to track serious side effects. Researchers hope this drug could offer a safe, long-term option to help people quit nicotine products.

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) 3 mg tablets taken three times daily
What this could lead to
If successful, this could confirm that long-term use of cytisinicline is safe, supporting its approval as a treatment to help people quit smoking or vaping.
What could go wrong
This is a safety study, not designed to prove effectiveness. Side effects or serious adverse events may still emerge, and results may not apply to all smokers or vapers.

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

479 people

The number who actually took part.

Started

May 2024

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

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. Prior participation in the ORCA-2, ORCA-3 or ORCA-V1 clinical studies. 2. Former ORCA-2/ORCA-3 and ORCA-V1 subjects who are current daily cigarette smokers and/or daily nicotine-containing electronic cigarette users. Amount of daily combustible and/or nicotine containing electronic cigarette use at baseline is determined by subject self-report. 3. At Screening, subjects must have expired carbon monoxide (CO) ≥10 ppm if self-reporting as smokers or ≥30 ng/mL cotinine using a point-of-care cotinine oral fluid screening device if self-reporting as users of nicotine containing electronic cigarettes. 4. Willing to initiate cytisinicline treatment on the day after enrollment and set a quit date within 14 days of starting treatment. 5. Willing to actively participate in the study's 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. Known hypersensitivity to cytisinicline or any of the excipients. 2. Clinically significant abnormal screening serum chemistry or hematology values. 3. Clinically significant abnormal screening 12-lead ECG determined after minimum of 5 minutes in supine position (ie, requiring treatment or further assessment). 4. Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure. 5. Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg). 6. Currently psychotic or having had a psychotic event within 3 months prior to screening; currently having suicidal ideation or risk for suicide (corresponding to question 4 or 5 on the screening C-SSRS OR "Yes" to any suicidal behavior question on the screening C-SSRS with clear suicidal intent or previous attempt); or current symptoms of moderate to severe depression (depression score ≥11 on the HADS) at screening. If any subject becomes psychotic during the study, they must be removed from cytisinicline treatment and/or additional study visits. 7. Severe renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min on screening lab (estimated with the Cockroft-Gault equation). 8. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN) on screening lab. 9. Women who are pregnant or breast-feeding. 10. Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include: * True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\]. * Barrier methods: * diaphragm * cervical cap * contraceptive sponge * Hormonal methods: * Oral contraceptives * Vaginal ring such as NuvaRing * Skin patch such as Xulane * Injection such as Depro-Provera * Implantable rod such as Nexplanon 11. Participation in a clinical study with an investigational drug in the 4 weeks prior to enrollment. 12. 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 Vaping cessation

Contacts and locations

Locations

  • Accel Research Sites Network - DeLand Clinical Research Unit

    DeLand, Florida, 32720, United States

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134, United States

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912, United States

  • Alliance for Multispecialty Research, LLC

    Oak Brook, Illinois, 60523, United States

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207, United States

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509, 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

    Norman, Oklahoma, 73069, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909, United States

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502, United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213, United States

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203, United States

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281, United States

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Global Medical Institutes LLC; Princeton Medical Institute

    Princeton, New Jersey, 08540, United States

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606, United States

  • Insight Research Institute

    Flint, Michigan, 48507, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Little Rock Allergy & Asthma Clinical Research Center

    Little Rock, Arkansas, 72205, United States

  • Massachusetts General Hospital - Clinical Genetic Facility

    Boston, Massachusetts, 02114, United States

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714, United States

  • Precision Clinical Research

    Sunrise, Florida, 33351, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

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