Trial · NCT00935818

Varenicline and Bupropion for Smoking Cessation

NCT00935818, Phase 2, Phase 3, Completed, Mayo Clinic; results first posted 2014-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Varenicline and Bupropion for Smoking Cessation. Trials, record NCT00935818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00935818

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Varenicline and Bupropion for Smoking Cessation
NCT number: NCT00935818
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 506 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Smoking
Interventions: Varenicline, placebo, bupropion SR
First posted: 2009-07-09
Last updated: 2014-05-09
Results first posted: 2014-04-24

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.	3 months	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?"
Primary	Point Prevalence Abstinence at 3 Months.	3 months	biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.
Secondary	Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.	6 months
Secondary	Weight Gain From Baseline to 3 Months	3 months	Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit
Secondary	Point Prevalence Abstinence at 6 Months.	6 months	Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.
Secondary	Prolonged Abstinence at 12 Months	12 months
Secondary	Point Prevalence Abstinence at 12 Months	12 months	Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.	3 months	intention-to-treat (all randomized subjects included)	participants	NUMBER
SECONDARY	Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.	6 months	intention to treat - all subjects	participants	NUMBER
SECONDARY	Weight Gain From Baseline to 3 Months	3 months	analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence	kilograms	MEAN
PRIMARY	Point Prevalence Abstinence at 3 Months.	3 months	intent to treat - all subjects	participants	NUMBER
SECONDARY	Point Prevalence Abstinence at 6 Months.	6 months	Intention to treat - all subjects	participants	NUMBER
SECONDARY	Prolonged Abstinence at 12 Months	12 months	intention to treat - all subjects	participants	NUMBER
SECONDARY	Point Prevalence Abstinence at 12 Months	12 months		participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.	Varenicline and Buproprion SR	132		participants
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.	Varenicline and Placebo	111		participants
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.	Varenicline and Buproprion SR	91		participants
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.	Varenicline and Placebo	71		participants
Weight Gain From Baseline to 3 Months	Varenicline and Buproprion SR	1.1	Standard Deviation 3.4	kilograms
Weight Gain From Baseline to 3 Months	Varenicline and Placebo	2.5	Standard Deviation 2.7	kilograms
Point Prevalence Abstinence at 3 Months.	Varenicline and Buproprion SR	140		participants
Point Prevalence Abstinence at 3 Months.	Varenicline and Placebo	125		participants
Point Prevalence Abstinence at 6 Months.	Varenicline and Buproprion SR	95		participants
Point Prevalence Abstinence at 6 Months.	Varenicline and Placebo	82		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Varenicline and Buproprion SR	249
Overall Study	STARTED	Varenicline and Placebo	257
Overall Study	End of Medication Phase	Varenicline and Buproprion SR	182
Overall Study	End of Medication Phase	Varenicline and Placebo	184
Overall Study	COMPLETED	Varenicline and Buproprion SR	158
Overall Study	COMPLETED	Varenicline and Placebo	157
Overall Study	NOT COMPLETED	Varenicline and Buproprion SR	91
Overall Study	NOT COMPLETED	Varenicline and Placebo	100

Source ClinicalTrials.gov

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	sleep disturbance	General disorders	Varenicline and Buproprion SR	100	249
other	sleep disturbance	General disorders	Varenicline and Placebo	91	257
other	nausea	Gastrointestinal disorders	Varenicline and Buproprion SR	55	249
other	nausea	Gastrointestinal disorders	Varenicline and Placebo	54	257
other	constipation	Gastrointestinal disorders	Varenicline and Buproprion SR	26	249
other	constipation	Gastrointestinal disorders	Varenicline and Placebo	19	257
other	headache	Nervous system disorders	Varenicline and Buproprion SR	21	249
other	headache	Nervous system disorders	Varenicline and Placebo	22	257
other	irritability	General disorders	Varenicline and Buproprion SR	21	249
other	irritability	General disorders	Varenicline and Placebo	12	257

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varenicline and Buproprion SR
Total, all-cause mortality	Varenicline and Placebo
Total, other adverse events	Varenicline and Buproprion SR	165	249
Total, other adverse events	Varenicline and Placebo	161	257
Total, serious adverse events	Varenicline and Buproprion SR	6	249
Total, serious adverse events	Varenicline and Placebo	6	257

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24399554	RESULT	PubMed
34611902	DERIVED	PubMed
37142273	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA138417	Combination Therapy with Varenicline and Bupropion for Smoking Cessation	EBBERT, JON O.	MAYO CLINIC ROCHESTER	NATIONAL CANCER INSTITUTE	2009 to 2012

Source NIH RePORTER

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Varenicline and Buproprion SR vs Varenicline and Placebo: Prolonged Abstinence at 12 Months	Trial comparisons
Varenicline and Buproprion SR vs Varenicline and Placebo: Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.	Trial comparisons
Varenicline and Buproprion SR vs Varenicline and Placebo: Point Prevalence Abstinence at 6 Months.	Trial comparisons
Varenicline and Buproprion SR vs Varenicline and Placebo: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.	Trial comparisons
Varenicline and Buproprion SR vs Varenicline and Placebo: Point Prevalence Abstinence at 3 Months.	Trial comparisons
Varenicline and Buproprion SR vs Varenicline and Placebo: Point Prevalence Abstinence at 12 Months	Trial comparisons
Varenicline and Buproprion SR vs Varenicline and Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00935818

GET https://conductscience.org/api/trials/v1/NCT00935818/events?page=2

API reference For AI assistants