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
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Achieve Life Sciences
- Enrollment
- 800
- Primary Endpoint
- Primary Efficacy Objective
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
- •Positive urinary drugs of abuse screen determined within 28 days before the first dose of study drug. (Note: Although THC is part of the standard drug screen, it is not necessarily exclusionary. Refer to exclusion criteria #2).
- •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.
Arms & Interventions
Arm A
12 weeks of placebo + behavioral support; 400 subjects
Intervention: Placebo (Drug)
Arm A
12 weeks of placebo + behavioral support; 400 subjects
Intervention: Behavioral Support (Behavioral)
Arm B
12 weeks cytisinicline + behavioral support; 400 subjects
Intervention: Cytisinicline (Drug)
Arm B
12 weeks cytisinicline + behavioral support; 400 subjects
Intervention: Behavioral Support (Behavioral)
Outcomes
Primary Outcomes
Primary Efficacy Objective
Time Frame: Randomization to Week 24 follow-up visit
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 post-randomization as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support). Successful vaping cessation is defined as weekly vaping abstinence during the last 4 weeks of the 12-week treatment period (Week 9 through Week 12) using quantitative cotinine levels at \<10 ng/mL for biochemical verification and subject's self-report of no vaping using a daily electronic diary
Secondary Outcomes
No secondary outcomes reported