Trial Outcomes & Findings for Varenicline and Bupropion for Smoking Cessation (NCT NCT00935818)
NCT ID: NCT00935818
Last Updated: 2014-05-09
Results Overview
Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question "Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
506 participants
Primary outcome timeframe
3 months
Results posted on
2014-05-09
Participant Flow
Recruitment was between October 2009 and April 2012. Volunteers from local communities of Rochester, MN, Minneapolis, MN and LaCrosse, WI, were recruited using newspaper classified ads, radio, TV, internet ads, print ads in magazines, word of mouth, and volunteer wait lists.
Study subjects who consented, were screened for entry criteria, and asked to return for a physical exam and medical history. If eligible and still interested, the volunteer was asked to return to the baseline visit at which time they would receive the study medication assignment.
Participant milestones
| Measure |
Varenicline and Buproprion SR
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
249
|
257
|
|
Overall Study
End of Medication Phase
|
182
|
184
|
|
Overall Study
COMPLETED
|
158
|
157
|
|
Overall Study
NOT COMPLETED
|
91
|
100
|
Reasons for withdrawal
| Measure |
Varenicline and Buproprion SR
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
45
|
50
|
|
Overall Study
Lost to Follow-up
|
40
|
42
|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Varenicline and Bupropion for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
234 Participants
n=99 Participants
|
253 Participants
n=107 Participants
|
487 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
41.9 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
42.1 years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
267 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, non-hispanic
|
234 participants
n=99 Participants
|
240 participants
n=107 Participants
|
474 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
other
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
smoking rate
|
19.5 cigarettes per day
STANDARD_DEVIATION 7.3 • n=99 Participants
|
19.7 cigarettes per day
STANDARD_DEVIATION 7.9 • n=107 Participants
|
19.6 cigarettes per day
STANDARD_DEVIATION 7.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: intention-to-treat (all randomized subjects included)
Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question "Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.
|
132 participants
|
111 participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: intent to treat - all subjects
biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Point Prevalence Abstinence at 3 Months.
|
140 participants
|
125 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: intention to treat - all subjects
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.
|
91 participants
|
71 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence
Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=131 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=111 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Weight Gain From Baseline to 3 Months
|
1.1 kilograms
Standard Deviation 3.4
|
2.5 kilograms
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intention to treat - all subjects
Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Point Prevalence Abstinence at 6 Months.
|
95 participants
|
82 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: intention to treat - all subjects
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Prolonged Abstinence at 12 Months
|
77 participants
|
63 participants
|
SECONDARY outcome
Timeframe: 12 monthsBiochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days
Outcome measures
| Measure |
Varenicline and Buproprion SR
n=249 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 Participants
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Point Prevalence Abstinence at 12 Months
|
91 participants
|
75 participants
|
Adverse Events
Varenicline and Buproprion SR
Serious events: 6 serious events
Other events: 165 other events
Deaths: 0 deaths
Varenicline and Placebo
Serious events: 6 serious events
Other events: 161 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline and Buproprion SR
n=249 participants at risk
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 participants at risk
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
trauma
|
0.40%
1/249 • Number of events 1
|
0.00%
0/257
|
|
Injury, poisoning and procedural complications
food poisining
|
0.00%
0/249
|
0.39%
1/257 • Number of events 1
|
|
Gastrointestinal disorders
diverticulitis
|
0.00%
0/249
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/249
|
0.39%
1/257 • Number of events 1
|
|
Cardiac disorders
acute coronary syndrome
|
0.40%
1/249 • Number of events 1
|
0.00%
0/257
|
|
Blood and lymphatic system disorders
deep vein thrombosis
|
0.40%
1/249 • Number of events 1
|
0.00%
0/257
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.40%
1/249 • Number of events 1
|
0.00%
0/257
|
|
Cardiac disorders
coronary artery disease
|
0.40%
1/249 • Number of events 1
|
0.00%
0/257
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.40%
1/249 • Number of events 1
|
0.00%
0/257
|
|
Immune system disorders
death
|
0.00%
0/249
|
0.39%
1/257 • Number of events 1
|
|
Psychiatric disorders
attempted suicide
|
0.00%
0/249
|
0.39%
1/257 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/249
|
0.39%
1/257 • Number of events 1
|
Other adverse events
| Measure |
Varenicline and Buproprion SR
n=249 participants at risk
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks
|
Varenicline and Placebo
n=257 participants at risk
Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.
varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks
|
|---|---|---|
|
General disorders
sleep disturbance
|
40.2%
100/249
|
35.4%
91/257
|
|
Gastrointestinal disorders
nausea
|
22.1%
55/249
|
21.0%
54/257
|
|
Gastrointestinal disorders
constipation
|
10.4%
26/249
|
7.4%
19/257
|
|
Nervous system disorders
headache
|
8.4%
21/249
|
8.6%
22/257
|
|
General disorders
irritability
|
8.4%
21/249
|
4.7%
12/257
|
|
General disorders
anxiety
|
7.2%
18/249
|
3.1%
8/257
|
|
General disorders
difficulty concentrating
|
5.6%
14/249
|
3.9%
10/257
|
|
General disorders
mood disturbance
|
5.2%
13/249
|
2.7%
7/257
|
|
General disorders
dizziness
|
4.0%
10/249
|
3.9%
10/257
|
|
General disorders
abnormal dreams
|
3.6%
9/249
|
7.4%
19/257
|
|
General disorders
restlessness
|
3.6%
9/249
|
1.9%
5/257
|
|
Psychiatric disorders
depressive symptoms
|
3.6%
9/249
|
0.78%
2/257
|
|
General disorders
fatigue
|
2.8%
7/249
|
6.6%
17/257
|
|
General disorders
dry mouth
|
2.8%
7/249
|
3.5%
9/257
|
|
Gastrointestinal disorders
dispepsia
|
2.0%
5/249
|
0.39%
1/257
|
|
Gastrointestinal disorders
flatulance
|
0.40%
1/249
|
3.5%
9/257
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place