Trial Outcomes & Findings for Effects of Varenicline on Smoking Reminders (NCT NCT01524627)
NCT ID: NCT01524627
Last Updated: 2017-08-17
Results Overview
Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
last week of treatment (1-8 weeks)
Results posted on
2017-08-17
Participant Flow
Subjects were recruited from 1/2012-7/2015. Methods used to recruit were flyers, advertisements on public transportation, Craigslist, word of mouth. 596 potential subjects were phone screened, 124 of those successfully consented, 43 were randomized
Participant milestones
| Measure |
Placebo
Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective as Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
Varenicline
Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective as Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
Varenicline
Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Effects of Varenicline on Smoking Reminders
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Participants will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
Varenicline
n=21 Participants
Subjects will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: last week of treatment (1-8 weeks)Population: Population was the number of randomized subjects who participated in any treatment length. One subject per group was not included in this analysis as one withdrew a few days after their first scan and the other was lost to follow up after their first scan.
Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
Varenicline
n=20 Participants
Subjects will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
|---|---|---|
|
Cigarettes Per Day
Baseline
|
15.7 cigarettes per day
Standard Error 2.5
|
14.3 cigarettes per day
Standard Error 1.8
|
|
Cigarettes Per Day
Following Treatment
|
9.8 cigarettes per day
Standard Error 2.6
|
5.3 cigarettes per day
Standard Error 1.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Varenicline
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 |
Placebo
n=22 participants at risk
Participants will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
Varenicline
n=21 participants at risk
Subjects will receive either varenicline or placebo
Varenicline or placebo: Varenicline or placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Coughing (mild)
|
9.1%
2/22 • Number of events 2 • Collected over 5 years during a subject's week 1-8
|
0.00%
0/21 • Collected over 5 years during a subject's week 1-8
|
|
Nervous system disorders
Dizziness (mild)
|
13.6%
3/22 • Number of events 3 • Collected over 5 years during a subject's week 1-8
|
0.00%
0/21 • Collected over 5 years during a subject's week 1-8
|
|
Nervous system disorders
Headache (mild)
|
22.7%
5/22 • Number of events 5 • Collected over 5 years during a subject's week 1-8
|
0.00%
0/21 • Collected over 5 years during a subject's week 1-8
|
|
Gastrointestinal disorders
Nausea (mild)
|
13.6%
3/22 • Number of events 3 • Collected over 5 years during a subject's week 1-8
|
33.3%
7/21 • Number of events 10 • Collected over 5 years during a subject's week 1-8
|
|
Gastrointestinal disorders
Nausea (moderate)
|
9.1%
2/22 • Number of events 2 • Collected over 5 years during a subject's week 1-8
|
9.5%
2/21 • Number of events 2 • Collected over 5 years during a subject's week 1-8
|
|
Nervous system disorders
Sedation/Drowsiness (mild)
|
13.6%
3/22 • Number of events 3 • Collected over 5 years during a subject's week 1-8
|
9.5%
2/21 • Number of events 2 • Collected over 5 years during a subject's week 1-8
|
|
Skin and subcutaneous tissue disorders
Skin Irritation (mild)
|
0.00%
0/22 • Collected over 5 years during a subject's week 1-8
|
9.5%
2/21 • Number of events 2 • Collected over 5 years during a subject's week 1-8
|
|
Nervous system disorders
Vivid Dreams (mild)
|
9.1%
2/22 • Number of events 5 • Collected over 5 years during a subject's week 1-8
|
0.00%
0/21 • Collected over 5 years during a subject's week 1-8
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection (moderate)
|
9.1%
2/22 • Number of events 2 • Collected over 5 years during a subject's week 1-8
|
0.00%
0/21 • Collected over 5 years during a subject's week 1-8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place