Trial Outcomes & Findings for Varenicline OTC Trial on Efficacy and Safety (NCT NCT03557294)
NCT ID: NCT03557294
Last Updated: 2024-09-19
Results Overview
Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
313 participants
Primary outcome timeframe
Week 12
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
1.0mg Varenicline b.i.d.
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
105
|
|
Overall Study
COMPLETED
|
70
|
66
|
76
|
|
Overall Study
NOT COMPLETED
|
34
|
38
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
Baseline characteristics by cohort
| Measure |
1.0mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
n=105 Participants
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.0 Years
STANDARD_DEVIATION 10.5 • n=104 Participants
|
51.4 Years
STANDARD_DEVIATION 11.2 • n=104 Participants
|
51.0 Years
STANDARD_DEVIATION 12.3 • n=105 Participants
|
51.5 Years
STANDARD_DEVIATION 11.3 • n=313 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=103 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
65 Participants
n=104 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
33 Participants
n=105 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
154 Participants
n=312 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
|
Sex: Female, Male
Male
|
47 Participants
n=103 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
39 Participants
n=104 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
72 Participants
n=105 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
158 Participants
n=312 Participants • One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
60 Participants
n=104 Participants
|
58 Participants
n=104 Participants
|
63 Participants
n=105 Participants
|
181 Participants
n=313 Participants
|
|
Race/Ethnicity, Customized
Race · African-American
|
40 Participants
n=104 Participants
|
44 Participants
n=104 Participants
|
35 Participants
n=105 Participants
|
119 Participants
n=313 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=104 Participants
|
1 Participants
n=104 Participants
|
2 Participants
n=105 Participants
|
3 Participants
n=313 Participants
|
|
Race/Ethnicity, Customized
Race · AI/AN
|
0 Participants
n=104 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=105 Participants
|
1 Participants
n=313 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=104 Participants
|
1 Participants
n=104 Participants
|
1 Participants
n=105 Participants
|
2 Participants
n=313 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
4 Participants
n=104 Participants
|
0 Participants
n=104 Participants
|
3 Participants
n=105 Participants
|
7 Participants
n=313 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=104 Participants
|
104 participants
n=104 Participants
|
105 participants
n=105 Participants
|
313 participants
n=313 Participants
|
PRIMARY outcome
Timeframe: Week 12Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence
Outcome measures
| Measure |
1.0mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
n=105 Participants
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
|---|---|---|---|
|
The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine
|
17 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 12 visitParticipants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - point prevalence abstinence
Outcome measures
| Measure |
1.0mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
n=105 Participants
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
|---|---|---|---|
|
Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence
|
25 Participants
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 26Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide
Outcome measures
| Measure |
1.0mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
n=104 Participants
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
n=105 Participants
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
|---|---|---|---|
|
Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes
|
16 Participants
|
11 Participants
|
11 Participants
|
Adverse Events
1.0mg Varenicline b.i.d.
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
0.5mg Varenicline b.i.d.
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
0.0mg Placebo Varenicline b.i.d.
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1.0mg Varenicline b.i.d.
n=104 participants at risk
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
n=104 participants at risk
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
n=105 participants at risk
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma Attack
|
0.00%
0/104 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
0.00%
0/104 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
0.95%
1/105 • Number of events 1 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.00%
0/104 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
0.00%
0/104 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
0.95%
1/105 • Number of events 1 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
Other adverse events
| Measure |
1.0mg Varenicline b.i.d.
n=104 participants at risk
Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.5mg Varenicline b.i.d.
n=104 participants at risk
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
|
0.0mg Placebo Varenicline b.i.d.
n=105 participants at risk
Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
28.8%
30/104 • Number of events 32 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
22.1%
23/104 • Number of events 23 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
7.6%
8/105 • Number of events 8 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
|
General disorders
Insomnia
|
6.7%
7/104 • Number of events 7 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
2.9%
3/104 • Number of events 3 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
9.5%
10/105 • Number of events 10 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
|
Psychiatric disorders
Irritability
|
5.8%
6/104 • Number of events 6 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
8.7%
9/104 • Number of events 9 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
9.5%
10/105 • Number of events 10 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
|
General disorders
Vivid Dreams
|
21.2%
22/104 • Number of events 22 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
18.3%
19/104 • Number of events 19 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
16.2%
17/105 • Number of events 17 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
|
Gastrointestinal disorders
Constipation
|
8.7%
9/104 • Number of events 9 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
8.7%
9/104 • Number of events 9 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
3.8%
4/105 • Number of events 4 • Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place