Trial Outcomes & Findings for Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts (NCT NCT01023659)
NCT ID: NCT01023659
Last Updated: 2018-01-24
Results Overview
7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
893 participants
Primary outcome timeframe
6-month
Results posted on
2018-01-24
Participant Flow
Participants visited the study website, provided consent and completed an on-line assessment. Eligible participants received a personalized script to take to their physician, who could prescribe varenicline or bupropion for 12 weeks, or neither.
Participant milestones
| Measure |
Bupropion + Motivational Emails
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Motivational Emails
participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Varenicline + Motivational Emails
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
258
|
365
|
264
|
|
Overall Study
COMPLETED
|
185
|
137
|
165
|
|
Overall Study
NOT COMPLETED
|
73
|
228
|
99
|
Reasons for withdrawal
| Measure |
Bupropion + Motivational Emails
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Motivational Emails
participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Varenicline + Motivational Emails
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
73
|
228
|
99
|
Baseline Characteristics
Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts
Baseline characteristics by cohort
| Measure |
Bupropion + Motivational Emails
n=258 Participants
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Motivational Emails
n=365 Participants
participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Varenicline + Motivational Emails
n=264 Participants
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
|
Total
n=887 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
503 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
384 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
258 participants
n=5 Participants
|
365 participants
n=7 Participants
|
264 participants
n=5 Participants
|
887 participants
n=4 Participants
|
|
Education level- less than high school diploma
|
59 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
211 Participants
n=4 Participants
|
|
Annual household income:$20,000 or less
|
116 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
373 Participants
n=4 Participants
|
|
# Participants currently employed
|
136 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
472 Participants
n=4 Participants
|
|
# cigarettes smoked per day
10-19 cpd
|
81 participants
n=5 Participants
|
131 participants
n=7 Participants
|
87 participants
n=5 Participants
|
299 participants
n=4 Participants
|
|
# cigarettes smoked per day
20-29 cpd
|
133 participants
n=5 Participants
|
186 participants
n=7 Participants
|
138 participants
n=5 Participants
|
457 participants
n=4 Participants
|
|
# cigarettes smoked per day
30 + cpd
|
44 participants
n=5 Participants
|
48 participants
n=7 Participants
|
39 participants
n=5 Participants
|
131 participants
n=4 Participants
|
|
# participants who smoke first morning cigarette within 5 minutes
|
122 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
426 Participants
n=4 Participants
|
|
Years since started smoking daily
|
29.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
# participants with less than 3 quit attempts
|
140 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
478 Participants
n=4 Participants
|
|
Confidence in Quitting
|
7.8 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
# Participants who report previous use of smoking cessation medication
|
142 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
470 Participants
n=4 Participants
|
|
# participants with longest period of abstinence from smoking- less than 1 week
less than 1 week
|
75 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
# participants with longest period of abstinence from smoking- less than 1 week
1 week or more
|
183 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
623 Participants
n=4 Participants
|
|
Participants who report all or most of my friends smoke
|
80 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Lives with other smoker(s)
|
140 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
498 Participants
n=4 Participants
|
|
History of drug or alcohol problem
|
40 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6-monthPopulation: Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)
7-day point prevalence of abstinence was assessed by the question "Have you had a cigarette, even a puff, in the past 7 days?"
Outcome measures
| Measure |
Bupropion + Motivational Emails
n=185 Participants
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Motivational Emails
n=137 Participants
participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Varenicline + Motivational Emails
n=165 Participants
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
|
|---|---|---|---|
|
7-day Point Prevalence of Abstinence
|
45 Participants
|
22 Participants
|
50 Participants
|
PRIMARY outcome
Timeframe: End of TreatmentPopulation: total number of eligible participants in study
Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed
Outcome measures
| Measure |
Bupropion + Motivational Emails
n=893 Participants
participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.
bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Motivational Emails
participants receive weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
|
Varenicline + Motivational Emails
participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.
motivational emails : brief motivational emails, sent weekly for 12 weeks
varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks
|
|---|---|---|---|
|
Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician
|
588 Participants
|
—
|
—
|
Adverse Events
Bupropion + Motivational Emails
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Emails
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Varenicline + Motivational Emails
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place