A Study of Cytisinicline for Vaping Cessation in Adult Smokers

NCT05431387 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ACH-CYT-10
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.

Conditions

Vaping; E-Cig Use

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Vaping Abstinence From Week 9 to 12

  Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.

  Weeks 9 to 12

Secondary Outcomes (5)

• Percentage of Participants With Vaping Abstinence From Week 3 to 6

  Weeks 3 to 6

• Percentage of Participants With Vaping Abstinence From Week 6 to 9

  Weeks 6 to 9

• Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates)

  Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12

  Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Percentage of Participants With Vaping Abstinence From Week 9 to 16

  Weeks 9 to 16

Study Arms (2)

Placebo + Behavioral Support

PLACEBO COMPARATOR

one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks

Drug: Placebo; Behavioral: Behavioral support

Cytisinicline + Behavioral Support

EXPERIMENTAL

one cytisinicline tablet PO TID plus behavioral support for 12 weeks

Drug: cytisinicline; Behavioral: Behavioral support

Interventions

cytisinicline DRUG

film-coated oral tablets containing 3 mg cytisinicline

Also known as: cytisine

Cytisinicline + Behavioral Support

Placebo DRUG

film-coated oral tablets containing matched placebo

Placebo + Behavioral Support

Behavioral support BEHAVIORAL

Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the participant about their attempt to quit vaping. Each session will last approximately 10 minutes.

Cytisinicline + Behavioral Support; Placebo + Behavioral Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age ≥ 18 years.
• Test positive for cotinine using the Alere iScreen® OFD Cotinine Oral Fluid Screening Device (Positive testing at ≥ 30 ng/mL cotinine level).
• 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.
• Willing to initiate study treatment on the day after randomization and set a quit date within 7-14 days of starting treatment.
• 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.

You may not qualify if:

• 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).
• Expired carbon monoxide (CO) levels ≥ 10 ppm, indicating recent combustible tobacco use.
• More than 1 study participant in same household during the study treatment period.
• Known hypersensitivity to cytisinicline or any of the excipients.
• 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).
• Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e., requiring treatment or monitoring).
• 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).
• Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
• Current uncontrolled hypertension (blood pressure ≥ 160/100 mmHg).
• 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.
• Renal impairment defined as a creatinine clearance (CrCl) \< 60 mL/min (estimated with the Cockroft-Gault equation).
• Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.0 x the upper limit of normal (ULN).
• 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.)
• Women who are pregnant or breast-feeding.
• 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.

Sponsors & Collaborators

• Achieve Life Sciences: lead

Study Sites (5)

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Massachusetts General Hospital - Clinical Genetic Research Facility

Boston, Massachusetts, 02114, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Rigotti NA, Benowitz NL, Prochaska JJ, Cain DF, Ball J, Clarke A, Blumenstein BA, Jacobs C. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):922-930. doi: 10.1001/jamainternmed.2024.1313.

  PMID: 38709500 DERIVED

MeSH Terms

Conditions

Vaping

Interventions

cytisine; Behavior Therapy

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Julie Ball, Vice President, Clinical Operations
• Organization: Achieve Life Sciences

jball@achievelifesciences.com

425-686-1540

Study Officials

• Daniel Cain, Vice-President Clinical Research

  Achieve Life Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 13, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)