Trial Outcomes & Findings for The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior (NCT NCT00580853)

NCT ID: NCT00580853

Last Updated: 2018-02-08

Results Overview

minutes to start smoking (range 0 to 50 minutes)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: 0 to 50 minutes
• Results posted on: 2018-02-08

Participant Flow

Participant milestones

Measure	Varenicline varenicline 2mg/day varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).	Bupropion Bupropion 300mg/day bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).	Placebo Placebo Control Placebo: Placebo
Overall Study STARTED	20	21	21
Overall Study COMPLETED	20	21	21
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

Baseline characteristics by cohort

Measure	Varenicline n=20 Participants varenicline 2mg/day varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).	Bupropion n=21 Participants Bupropion 300mg/day bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).	Placebo n=21 Participants Placebo Control Placebo: Placebo	Total n=62 Participants Total of all reporting groups
Age, Continuous	34.95 years STANDARD_DEVIATION 11.36 • n=5 Participants	34.95 years STANDARD_DEVIATION 9.70 • n=7 Participants	36.47 years STANDARD_DEVIATION 10.95 • n=5 Participants	35.47 years STANDARD_DEVIATION 6.95 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants

PRIMARY outcome

Timeframe: 0 to 50 minutes

Population: Subsample with high nicotine dependence

minutes to start smoking (range 0 to 50 minutes)

Outcome measures

Measure	Varenicline n=8 Participants varenicline 2mg/day varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).	Bupropion n=9 Participants Bupropion 300mg/day bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).	Placebo n=10 Participants Placebo Control Placebo: Placebo
Latency to Initiate Ad-lib Smoking Session	38.138 minutes Standard Error 6.268	39.416 minutes Standard Error 5.939	19.249 minutes Standard Error 6.196

SECONDARY outcome

Timeframe: 60 minutes

number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period

Outcome measures

Measure	Varenicline n=20 Participants varenicline 2mg/day varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).	Bupropion n=21 Participants Bupropion 300mg/day bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).	Placebo n=21 Participants Placebo Control Placebo: Placebo
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period	.713 number of cigarettes Standard Error .351	1.287 number of cigarettes Standard Error .342	2.085 number of cigarettes Standard Error .396

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Bupropion

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Varenicline n=20 participants at risk varenicline 2mg/day varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).	Bupropion n=21 participants at risk Bupropion 300mg/day bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).	Placebo n=21 participants at risk Placebo Control Placebo: Placebo
Gastrointestinal disorders Nausea	15.0% 3/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	14.3% 3/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	0.00% 0/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
Renal and urinary disorders need to urinate	25.0% 5/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	14.3% 3/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Dry mouth	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Insomnia	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
Gastrointestinal disorders Flatulence	15.0% 3/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	19.0% 4/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	14.3% 3/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Abnormal dreams	15.0% 3/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Discomfort	0.00% 0/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Headache	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	14.3% 3/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	19.0% 4/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Change in taste	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	19.0% 4/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Runny nose	30.0% 6/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	14.3% 3/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Change in appetite	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	19.0% 4/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	19.0% 4/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Trouble concentrating	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Sweating	0.00% 0/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	19.0% 4/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
Gastrointestinal disorders Heartburn	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Cough	5.0% 1/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	4.8% 1/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
General disorders Drowsiness	10.0% 2/20 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	14.3% 3/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.	9.5% 2/21 • Titration period (7 days) All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.

Additional Information

Sherry McKee PhD

Yale University

Phone: 203-737-3529

Email: sherry.mckee@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place