CompletedPhase 2

A Study of Cytisinicline for Vaping Cessation in Adult Smokers

United States160 participantsStarted 2022-07-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Percentage of Participants With Vaping Abstinence From Week 9 to 12

Timeframe: Weeks 9 to 12

Trial details

NCT IDNCT05431387

SponsorAchieve Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-28

Results submitted2025-12-23

View on ClinicalTrials.gov More Vaping trials