Trial Outcomes & Findings for Trial of Cytisine in Adult Smokers (NCT NCT03709823)
NCT ID: NCT03709823
Last Updated: 2020-05-18
Results Overview
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. The percentage of expected cigarettes smoked was computed as Y = (100 x N) / (T x R) where N represents total number of cigarettes smoked each day over the treatment period from Day 1 to Day 25; T represents number of post-randomization days where number of cigarettes smoked is recorded; and R represents the average number of cigarettes smoked daily over the 7-day screening period as baseline. T\*R represents the total number of cigarettes that would have been smoked without intervention over the number of recorded days. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
254 participants
Primary outcome timeframe
Day 1 through Day 25
Results posted on
2020-05-18
Participant Flow
Participant milestones
| Measure |
1.5 mg Cytisine, Commercial Schedule
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
25
|
52
|
50
|
26
|
|
Overall Study
COMPLETED
|
48
|
45
|
22
|
50
|
49
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
1.5 mg Cytisine, Commercial Schedule
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Other, Not Specified
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Trial of Cytisine in Adult Smokers
Baseline characteristics by cohort
| Measure |
1.5 mg Cytisine, Commercial Schedule
n=51 Participants
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
n=50 Participants
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
n=25 Participants
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
n=52 Participants
1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
n=50 Participants
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
n=26 Participants
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Average Number of Cigarettes Smoked per Day Over 7 Consecutive Days
|
17.6 cigarettes per day
STANDARD_DEVIATION 5.30 • n=5 Participants
|
18.0 cigarettes per day
STANDARD_DEVIATION 5.51 • n=7 Participants
|
16.7 cigarettes per day
STANDARD_DEVIATION 4.28 • n=5 Participants
|
18.0 cigarettes per day
STANDARD_DEVIATION 6.69 • n=4 Participants
|
18.0 cigarettes per day
STANDARD_DEVIATION 6.12 • n=21 Participants
|
18.0 cigarettes per day
STANDARD_DEVIATION 5.96 • n=10 Participants
|
17.8 cigarettes per day
STANDARD_DEVIATION 5.75 • n=115 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 13.20 • n=7 Participants
|
51.0 years
STANDARD_DEVIATION 15.16 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 13.67 • n=4 Participants
|
46.3 years
STANDARD_DEVIATION 12.88 • n=21 Participants
|
47.0 years
STANDARD_DEVIATION 12.64 • n=10 Participants
|
48.4 years
STANDARD_DEVIATION 13.04 • n=115 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
133 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
121 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
200 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
238 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 25The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. The percentage of expected cigarettes smoked was computed as Y = (100 x N) / (T x R) where N represents total number of cigarettes smoked each day over the treatment period from Day 1 to Day 25; T represents number of post-randomization days where number of cigarettes smoked is recorded; and R represents the average number of cigarettes smoked daily over the 7-day screening period as baseline. T\*R represents the total number of cigarettes that would have been smoked without intervention over the number of recorded days. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Outcome measures
| Measure |
1.5 mg Cytisine, Commercial Schedule
n=51 Participants
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
n=50 Participants
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
n=25 Participants
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
n=52 Participants
1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
n=50 Participants
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
n=26 Participants
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
|---|---|---|---|---|---|---|
|
Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment
|
26.62 percentage of cigarettes smoked
Standard Error 3.085
|
25.04 percentage of cigarettes smoked
Standard Error 3.123
|
47.10 percentage of cigarettes smoked
Standard Error 4.417
|
29.40 percentage of cigarettes smoked
Standard Error 3.046
|
32.50 percentage of cigarettes smoked
Standard Error 3.105
|
35.30 percentage of cigarettes smoked
Standard Error 4.392
|
PRIMARY outcome
Timeframe: Day 1 through Day 25The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Outcome measures
| Measure |
1.5 mg Cytisine, Commercial Schedule
n=51 Participants
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
n=50 Participants
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
n=51 Participants
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
|---|---|---|---|---|---|---|
|
Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, Commercial Schedule
|
26.68 percentage of expected cigarettes smoked
Standard Error 3.065
|
25.08 percentage of expected cigarettes smoked
Standard Error 3.100
|
41.29 percentage of expected cigarettes smoked
Standard Error 3.099
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 25The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Outcome measures
| Measure |
1.5 mg Cytisine, Commercial Schedule
n=52 Participants
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
n=50 Participants
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
n=51 Participants
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
|---|---|---|---|---|---|---|
|
Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, TID Schedule
|
29.29 percentage of expected cigarettes smoked
Standard Error 3.291
|
32.41 percentage of expected cigarettes smoked
Standard Error 3.355
|
41.71 percentage of expected cigarettes smoked
Standard Error 3.358
|
—
|
—
|
—
|
Adverse Events
1.5 mg Cytisine, Commercial Schedule
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
3.0 mg Cytisine, Commercial Schedule
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo, Commercial Schedule
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1.5 mg Cytisine, TID Schedule
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
3.0 mg Cytisine, TID Schedule
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo, TID Schedule
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1.5 mg Cytisine, Commercial Schedule
n=51 participants at risk
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
3.0 mg Cytisine, Commercial Schedule
n=50 participants at risk
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
|
Placebo, Commercial Schedule
n=25 participants at risk
Placebo tablets using the commercial 25-day titration schedule + behavioral support
|
1.5 mg Cytisine, TID Schedule
n=52 participants at risk
1.5 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
3.0 mg Cytisine, TID Schedule
n=50 participants at risk
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
|
Placebo, TID Schedule
n=26 participants at risk
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
1.9%
1/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
6.0%
3/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
3.8%
1/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Gastrointestinal disorders
Nausea
|
9.8%
5/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
6.0%
3/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
1/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
1.9%
1/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
6.0%
3/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
15.4%
4/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
General disorders
Fatigue
|
2.0%
1/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
2/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
1/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
5.8%
3/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
2.0%
1/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
3.8%
1/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
3.8%
2/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
2.0%
1/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
7.7%
2/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
2/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
12.0%
3/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
9.6%
5/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
6.0%
3/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
15.4%
4/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
2.0%
1/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
11.5%
6/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
2/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
7.7%
2/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Psychiatric disorders
Abnormal dreams
|
7.8%
4/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
14.0%
7/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
1/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
7.7%
4/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
6.0%
3/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
2.0%
1/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
2.0%
1/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
11.5%
3/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Psychiatric disorders
Insomnia
|
5.9%
3/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
8.0%
4/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
4.0%
1/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
7.7%
4/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
6.0%
3/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/51 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/25 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/52 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
0.00%
0/50 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
7.7%
2/26 • From 1st dose of study drug through Week 8 (± 3 days) post-randomization
|
Additional Information
Daniel Cain, Vice President, Clinical Research
Achieve Life Sciences
Phone: 425.686.1546
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