E-Cig Use, Vaping
Conditions
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.
Interventions
DRUGcytisinicline
film-coated oral tablets containing 3 mg cytisinicline
DRUGPlacebo
film-coated oral tablets containing matched placebo
BEHAVIORALBehavioral support
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.
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
1. Male or female subjects, age ≥ 18 years. 2. Test positive for cotinine using the Alere iScreen® OFD Cotinine Oral Fluid Screening Device (Positive testing at ≥ 30 ng/mL cotinine level). 3. 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. 4. Willing to initiate study treatment on the day after randomization and set a quit date within 7-14 days of starting treatment. 5. Willing to actively participate in the study's vaping cessation behavioral support provided throughout the study. 6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule. 7. Sign the Informed Consent Form.
Exclusion criteria
1. 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). 2. Expired carbon monoxide (CO) levels ≥ 10 ppm, indicating recent combustible tobacco use. 3. More than 1 study participant in same household during the study treatment period. 4. Known hypersensitivity to cytisinicline or any of the excipients. 5. 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). 6. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e., requiring treatment or monitoring). 7. 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). 8. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure. 9. Current uncontrolled hypertension (blood pressure ≥ 160/100 mmHg). 10. 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. 11. Renal impairment defined as a creatinine clearance (CrCl) \< 60 mL/min (estimated with the Cockroft-Gault equation). 12. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.0 x the upper limit of normal (ULN). 13. 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.) 14. Women who are pregnant or breast-feeding. 15. 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. 16. Participation in a clinical study with an investigational drug in the 4 weeks prior to study randomization. 17. Use of other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy \[NRT\]) in the 4 weeks prior to study randomization, any previous cytisinicline use, or planned use of these or other nicotine replacement medications during the study. 18. Any planned use during the study of combustible cigarettes or other nicotine-containing, non-vaping products (e.g., pipe tobacco, cigars, snuff, smokeless tobacco, hookah, ZYN pouches, etc). 19. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Vaping Abstinence From Week 9 to 12 | Weeks 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Vaping Abstinence From Week 3 to 6 | Weeks 3 to 6 | Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping. |
| Percentage of Participants With Vaping Abstinence From Week 6 to 9 | Weeks 6 to 9 | Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping. |
| 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 | The 7-day point prevalence abstinence endpoints are binary (success, failure), defined at each of the following visits: Week 2 to Week 12. Vaping abstinence used quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days. |
| 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 | Changes in nicotine vaping measured by weekly quantitative cotinine levels from Week 2 to Week 12. |
| Percentage of Participants With Vaping Abstinence From Week 9 to 16 | Weeks 9 to 16 | Vaping abstinence used quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping. Measurements were Weekly from Week 9 to 12 and one month for Week 16. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo + Behavioral Support one placebo tablet PO TID plus behavioral support for 12 weeks | 53 |
| Cytisinicline + Behavioral Support one cytisinicline tablet PO TID plus behavioral support for 12 weeks | 107 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 9 |
| Overall Study | Other, Not Specified | 1 | 4 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Placebo + Behavioral Support | Cytisinicline + Behavioral Support | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 10.94 | 33.6 years STANDARD_DEVIATION 11.15 | 33.6 years STANDARD_DEVIATION 11.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 103 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Other, Not Specified | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 43 Participants | 92 Participants | 135 Participants |
| Sex: Female, Male Female | 29 Participants | 54 Participants | 83 Participants |
| Sex: Female, Male Male | 24 Participants | 53 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 106 |
| other Total, other adverse events | 26 / 53 | 42 / 106 |
| serious Total, serious adverse events | 0 / 53 | 0 / 106 |
Outcome results
Primary
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.
Time frame: Weeks 9 to 12
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 9 to 12 | 15.1 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 9 to 12 | 31.8 percentage of participants |
Comparison: Abstinence from Week 9 to 12p-value: 0.03595% CI: [1.062, 7.098]Exact computations
p-value: 0.034895% CI: [1.133, 6.491]Exact computations
p-value: 0.01295% CI: [0.012, 0.284]Cochran-Mantel-Haenszel
Secondary
Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12
Changes in nicotine vaping measured by weekly quantitative cotinine levels from Week 2 to Week 12.
Time frame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: All randomized participants with an assessment at given time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 2 | -148.800 ng/mL | Standard Error 26.8978 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 8 | -113.940 ng/mL | Standard Error 27.3551 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 5 | -118.161 ng/mL | Standard Error 26.9808 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 9 | -109.008 ng/mL | Standard Error 27.6687 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 6 | -117.008 ng/mL | Standard Error 27.0665 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 10 | -133.935 ng/mL | Standard Error 27.2633 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 7 | -130.288 ng/mL | Standard Error 27.5571 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 11 | -123.616 ng/mL | Standard Error 27.3577 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 4 | -128.581 ng/mL | Standard Error 27.0594 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 12 | -110.402 ng/mL | Standard Error 27.3577 |
| Placebo + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 3 | -132.497 ng/mL | Standard Error 26.8617 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 12 | -167.731 ng/mL | Standard Error 18.8932 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 3 | -205.329 ng/mL | Standard Error 18.5404 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 4 | -202.672 ng/mL | Standard Error 18.5403 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 5 | -201.526 ng/mL | Standard Error 18.6277 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 2 | -181.306 ng/mL | Standard Error 18.5332 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 6 | -196.960 ng/mL | Standard Error 18.7278 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 7 | -179.597 ng/mL | Standard Error 18.6438 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 8 | -192.048 ng/mL | Standard Error 18.8551 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 9 | -195.014 ng/mL | Standard Error 18.8908 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 10 | -196.615 ng/mL | Standard Error 18.86 |
| Cytisinicline + Behavioral Support | Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12 | Change at Week 11 | -186.878 ng/mL | Standard Error 18.861 |
Comparison: Change at Week 2p-value: 195% CI: [-155.1192, 90.1072]Compound symmetry covariance matrix
Comparison: Change at Week 3p-value: 195% CI: [-195.3491, 49.6842]Compound symmetry covariance matrix
Comparison: Change at Week 4p-value: 195% CI: [-197.2184, 49.0381]Compound symmetry covariance matrix
Comparison: Change at Week 5p-value: 195% CI: [-206.4354, 39.7066]Compound symmetry covariance matrix
Comparison: Change at Week 6p-value: 195% CI: [-203.5009, 43.5976]Compound symmetry covariance matrix
Comparison: Change at Week 7p-value: 195% CI: [-174.2006, 75.5817]Compound symmetry covariance matrix
Comparison: Change at Week 8p-value: 195% CI: [-202.8196, 46.6046]Compound symmetry covariance matrix
Comparison: Change at Week 9p-value: 195% CI: [-211.7643, 39.7529]Compound symmetry covariance matrix
Comparison: Change at Week 10p-value: 195% CI: [-187.1187, 61.7592]Compound symmetry covariance matrix
Comparison: Change at Week 11p-value: 195% CI: [-187.9952, 61.4704]Compound symmetry covariance matrix
Comparison: Change at Week 12p-value: 195% CI: [-182.1302, 67.4727]Compound symmetry covariance matrix
Secondary
Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates)
The 7-day point prevalence abstinence endpoints are binary (success, failure), defined at each of the following visits: Week 2 to Week 12. Vaping abstinence used quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.
Time frame: Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 4 | 24.5 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 6 | 24.5 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 9 | 24.5 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 7 | 22.6 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 2 | 7.5 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 10 | 28.3 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 8 | 24.5 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 11 | 24.5 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 3 | 22.6 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 12 | 22.6 percentage of participants |
| Placebo + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 5 | 28.3 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 12 | 38.3 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 4 | 49.5 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 7 | 48.6 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 8 | 43.0 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 2 | 14.0 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 5 | 42.1 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 6 | 41.1 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 9 | 42.1 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 10 | 41.1 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 11 | 37.4 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates) | Week 3 | 33.6 percentage of participants |
Comparison: Week 2p-value: 0.303895% CI: [0.653, 7.309]Exact computations
Comparison: Week 2p-value: 0.303895% CI: [-0.058, 0.144]Exact computations
Comparison: Week 3p-value: 0.199695% CI: [0.817, 3.8]Exact computations
Comparison: Week 3p-value: 0.199695% CI: [-0.055, 0.251]Exact computations
Comparison: Week 4p-value: 0.003595% CI: [1.458, 6.414]Exact computations
Comparison: Week 4p-value: 0.003595% CI: [0.078, 0.395]Exact computations
Comparison: Week 5p-value: 0.118395% CI: [0.905, 3.809]Exact computations
Comparison: Week 5p-value: 0.118395% CI: [-0.035, 0.29]Exact computations
Comparison: Week 6p-value: 0.053295% CI: [1.035, 4.585]Exact computations
Comparison: Week 6p-value: 0.053295% CI: [-0.004, 0.311]Exact computations
Comparison: Week 7p-value: 0.001995% CI: [1.539, 6.989]Exact computations
Comparison: Week 7p-value: 0.001995% CI: [0.089, 0.4]Exact computations
Comparison: Week 8p-value: 0.024695% CI: [1.119, 4.944]Exact computations
Comparison: Week 8p-value: 0.024695% CI: [0.014, 0.33]Exact computations
Comparison: Week 9p-value: 0.036295% CI: [1.076, 4.762]Exact computations
Comparison: Week 9p-value: 0.036295% CI: [0.005, 0.321]Exact computations
Comparison: Week 10p-value: 0.121595% CI: [0.871, 3.668]Exact computations
Comparison: Week 10p-value: 0.121595% CI: [-0.044, 0.281]Exact computations
Comparison: Week 11p-value: 0.112395% CI: [0.882, 3.935]Exact computations
Comparison: Week 11p-value: 0.112395% CI: [-0.04, 0.274]Exact computations
Comparison: Week 12p-value: 0.051695% CI: [1.006, 4.626]Exact computations
Comparison: Week 12p-value: 0.051695% CI: [-0.011, 0.298]Exact computations
Secondary
Percentage of Participants With Vaping Abstinence From Week 3 to 6
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Time frame: Weeks 3 to 6
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 3 to 6 | 15.1 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 3 to 6 | 24.3 percentage of participants |
Comparison: Abstinence from Week 3 to 6p-value: 0.220595% CI: [0.766, 4.551]Exact computations
95% CI: [-0.058, 0.209]
Secondary
Percentage of Participants With Vaping Abstinence From Week 6 to 9
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Time frame: Weeks 6 to 9
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 6 to 9 | 17.0 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 6 to 9 | 30.8 percentage of participants |
Comparison: Abstinence from Week 6 to 9p-value: 0.08595% CI: [0.967, 5.202]Exact computations
95% CI: [-0.019, 0.263]
Secondary
Percentage of Participants With Vaping Abstinence From Week 9 to 16
Vaping abstinence used quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping. Measurements were Weekly from Week 9 to 12 and one month for Week 16.
Time frame: Weeks 9 to 16
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 9 to 16 | 13.2 percentage of participants |
| Cytisinicline + Behavioral Support | Percentage of Participants With Vaping Abstinence From Week 9 to 16 | 23.4 percentage of participants |
Comparison: Abstinence from Week 9 to 16p-value: 0.14795% CI: [0.82, 5.319]Exact computations
p-value: 0.14795% CI: [-0.044, 0.211]Exact computations