Vaping Cessation
Conditions
Keywords
vaping cessation
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).
Interventions
DRUGCytisinicline
Tablet, 3 times a day (TID), 12 weeks
DRUGPlacebo
Tablet, 3 times a day (TID), 12 weeks
BEHAVIORALBehavioral Support
16 behavioral support sessions, starting prior to randomization and through Week 12, 3 additional sessions during the follow-up period.
Sponsors
Achieve Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Objective | 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 |
Contacts
CONTACTJulie Ball; Vice President, Clinical Operations
CONTACTRoxann Becco; Sr. Director, Clinical Operations
STUDY_DIRECTORJulie Ball
Achieve Life Sciences, Inc.
Outcome results
None listed