Trial Outcomes & Findings for A Study of Cytisinicline for Vaping Cessation in Adult Smokers (NCT NCT05431387)
NCT ID: NCT05431387
Last Updated: 2026-01-14
Results Overview
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Weeks 9 to 12
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
107
|
|
Overall Study
Randomized and Treated
|
53
|
106
|
|
Overall Study
COMPLETED
|
42
|
89
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
|
Overall Study
Other, Not Specified
|
1
|
4
|
Baseline Characteristics
A Study of Cytisinicline for Vaping Cessation in Adult Smokers
Baseline characteristics by cohort
| Measure |
Placebo + Behavioral Support
n=53 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
Cytisinicline + Behavioral Support
n=107 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 10.94 • n=14 Participants
|
33.6 years
STANDARD_DEVIATION 11.15 • n=10 Participants
|
33.6 years
STANDARD_DEVIATION 11.05 • n=24 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=14 Participants
|
54 Participants
n=10 Participants
|
83 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=14 Participants
|
53 Participants
n=10 Participants
|
77 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=14 Participants
|
103 Participants
n=10 Participants
|
151 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=14 Participants
|
9 Participants
n=10 Participants
|
14 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=14 Participants
|
92 Participants
n=10 Participants
|
135 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
2 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Weeks 9 to 12Population: All randomized participants
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Outcome measures
| Measure |
Cytisinicline + Behavioral Support
n=107 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Placebo + Behavioral Support
n=53 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Vaping Abstinence From Week 9 to 12
|
31.8 percentage of participants
|
15.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 3 to 6Population: All randomized participants
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Outcome measures
| Measure |
Cytisinicline + Behavioral Support
n=107 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Placebo + Behavioral Support
n=53 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Vaping Abstinence From Week 3 to 6
|
24.3 percentage of participants
|
15.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6 to 9Population: All randomized participants
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Outcome measures
| Measure |
Cytisinicline + Behavioral Support
n=107 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Placebo + Behavioral Support
n=53 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Vaping Abstinence From Week 6 to 9
|
30.8 percentage of participants
|
17.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: All randomized participants
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.
Outcome measures
| Measure |
Cytisinicline + Behavioral Support
n=107 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Placebo + Behavioral Support
n=53 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
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
|
7.5 percentage of participants
|
|
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
|
22.6 percentage of participants
|
|
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
|
24.5 percentage of participants
|
|
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
|
28.3 percentage of participants
|
|
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
|
24.5 percentage of participants
|
|
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
|
22.6 percentage of participants
|
|
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
|
24.5 percentage of participants
|
|
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
|
24.5 percentage of participants
|
|
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
|
28.3 percentage of participants
|
|
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
|
24.5 percentage of participants
|
|
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
|
22.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12Population: All randomized participants with an assessment at given time point
Changes in nicotine vaping measured by weekly quantitative cotinine levels from Week 2 to Week 12.
Outcome measures
| Measure |
Cytisinicline + Behavioral Support
n=98 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Placebo + Behavioral Support
n=47 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12
Change at Week 11
|
-186.878 ng/mL
Standard Error 18.8610
|
-123.616 ng/mL
Standard Error 27.3577
|
|
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
|
-110.402 ng/mL
Standard Error 27.3577
|
|
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
|
-130.288 ng/mL
Standard Error 27.5571
|
|
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
|
-113.940 ng/mL
Standard Error 27.3551
|
|
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
|
-109.008 ng/mL
Standard Error 27.6687
|
|
Changes From Baseline in Quantitative Cotinine Levels From Week 2 to Week 12
Change at Week 10
|
-196.615 ng/mL
Standard Error 18.8600
|
-133.935 ng/mL
Standard Error 27.2633
|
|
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
|
-148.800 ng/mL
Standard Error 26.8978
|
|
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
|
-132.497 ng/mL
Standard Error 26.8617
|
|
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
|
-128.581 ng/mL
Standard Error 27.0594
|
|
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
|
-118.161 ng/mL
Standard Error 26.9808
|
|
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
|
-117.008 ng/mL
Standard Error 27.0665
|
SECONDARY outcome
Timeframe: Weeks 9 to 16Population: All randomized participants
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.
Outcome measures
| Measure |
Cytisinicline + Behavioral Support
n=107 Participants
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
Placebo + Behavioral Support
n=53 Participants
one placebo tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Vaping Abstinence From Week 9 to 16
|
23.4 percentage of participants
|
13.2 percentage of participants
|
Adverse Events
Placebo + Behavioral Support
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Cytisinicline + Behavioral Support
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo + Behavioral Support
n=53 participants at risk
one placebo tablet PO TID plus behavioral support for 12 weeks
|
Cytisinicline + Behavioral Support
n=106 participants at risk
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
10.4%
11/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Psychiatric disorders
Irritability
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
2.8%
3/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Psychiatric disorders
Abnormal dreams
|
1.9%
1/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
12.3%
13/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Psychiatric disorders
Anxiety
|
7.5%
4/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
9.4%
10/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
1.9%
2/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
4.7%
5/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
General disorders
Fatigue
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
5.7%
6/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Infections and infestations
COVID-19
|
13.2%
7/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
3.8%
4/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
3/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
5.7%
6/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
0.94%
1/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
0.00%
0/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
0.00%
0/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
2.8%
3/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Nervous system disorders
Headache
|
9.4%
5/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
6.6%
7/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
|
Nervous system disorders
Migraine
|
3.8%
2/53 • up to Week 16 ±3 days
Safety Set; all treated participants
|
0.94%
1/106 • up to Week 16 ±3 days
Safety Set; all treated participants
|
Additional Information
Julie Ball, Vice President, Clinical Operations
Achieve Life Sciences
Phone: 425-686-1540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
- Publication restrictions are in place
Restriction type: OTHER