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Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

NCT07392125•Achieve Life Sciences

View on ClinicalTrials.gov

Summary

This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only. A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms: * Arm B, 12 weeks cytisinicline + behavior support: N=400 or * Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects, age ≥18 years.
•Test positive for cotinine using a point-of-care Oral Fluid Screening Device (OFD) with positive detection at ≥30 ng/mL cotinine.
•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.
•Failed at least one previous attempt to stop vaping with or without therapeutic support.
•Willing to initiate study treatment on the day after randomization and set a quit date within Day 7 and Day 14.
•Willing to actively participate in the study's vaping cessation behavioral support provided throughout the study.
•Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
•Sign the Informed Consent Form.

Exclusion Criteria

•Currently smoking or having smoked within 3 months prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products such as heat not burn products or nicotine pouches (ie, dual users).
•Currently smoking/vaping cannabis or having smoked or vaped cannabis within 4 weeks (28 days) prior to study randomization or planned use while on study. Other methods of cannabis consumption, eg, edibles, tinctures, capsules, topicals, etc. are allowed.
•Expired Carbon Monoxide (CO) levels ≥6 ppm, indicating recent combustible tobacco or cannabis smoking.
•A score of 0-3 on the Penn State e-Cigarette Dependence Index indicating no dependence.
•More than 1 study subject in same household during the study treatment period.
•Known hypersensitivity to any of the excipients, previous cytisinicline treatment in a prior clinical study, or any previous use of cytisinicline.
•Clinically significant abnormal serum chemistry or hematology values, as determined by the investigator, within 28 days of randomization.
•Clinically significant abnormalities on screening visit 12-lead ECG, as determined by the investigator, after minimum of 5 minutes in supine position within 28 days of randomization.
•Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
•Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
+26 more criteria

Key Dates

Start Date

May 15, 2026

Primary Completion Date

November 15, 2026

Completion Date

September 30, 2027

Last Updated

February 6, 2026

Enrollment

800

ESTIMATED participants

Conditions

Vaping Cessation

Interventions

Cytisinicline

DRUG

Placebo

DRUG

Behavioral Support

BEHAVIORAL

Contacts

Julie Ball; Vice President, Clinical Operations

CONTACT

425-686-1540 jball@achievelifesciences.com

Roxann Becco; Sr. Director, Clinical Operations

CONTACT

312-288-1187 rbecco@achievelifesciences.com

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COMPLETEDPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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