Trial · NCT01303861

Concurrent Bupropion / Varenicline for Smoking Cessation

NCT01303861, Phase 3, Completed, Duke University; results first posted 2014-08-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Concurrent Bupropion / Varenicline for Smoking Cessation. Trials, record NCT01303861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01303861

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Trial

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

Title: Concurrent Bupropion / Varenicline for Smoking Cessation
NCT number: NCT01303861
Status: Completed
Phases: Phase 3
Enrollment: 702 participants, actual
Lead sponsor: Duke University
Conditions: Nicotine Dependence
Interventions: Varenicline, Bupropion, Nicotine patches, Nicotine Inhaler
First posted: 2011-02-25
Last updated: 2014-08-06
Results first posted: 2014-08-01

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Four-week Continuous Abstinence From Cigarette Smoking	Study week 8 thru week 11	The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.
Secondary	Seven Day Point Abstinence From Cigarette Smoking	Six months post quit date	Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.
Secondary	Continuous Cigarette Abstinence From Quit Date	From Quit date to end of treatment (week 11)	Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Four-week Continuous Abstinence From Cigarette Smoking	Study week 8 thru week 11	1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.	percentage of participants	NUMBER
SECONDARY	Seven Day Point Abstinence From Cigarette Smoking	Six months post quit date	1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.	participants	NUMBER
SECONDARY	Continuous Cigarette Abstinence From Quit Date	From Quit date to end of treatment (week 11)	1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.	participants	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Four-week Continuous Abstinence From Cigarette Smoking	Varenicline	25.93	95% Confidence Interval 17.97 to 35.25	percentage of participants
Four-week Continuous Abstinence From Cigarette Smoking	Nicotine Patches Only	46.94	95% Confidence Interval 32.53 to 61.73	percentage of participants
Four-week Continuous Abstinence From Cigarette Smoking	Nicotine Patches With Nicotine Inhaler	43.64	95% Confidence Interval 30.30 to 57.68	percentage of participants
Four-week Continuous Abstinence From Cigarette Smoking	Varenicline With Bupropion	39.82	95% Confidence Interval 30.73 to 49.46	percentage of participants
Seven Day Point Abstinence From Cigarette Smoking	Varenicline	18	95% Confidence Interval 11 to 27	participants
Seven Day Point Abstinence From Cigarette Smoking	Nicotine Patches Only	12	95% Confidence Interval 7 to 19	participants
Seven Day Point Abstinence From Cigarette Smoking	Nicotine Patches With Nicotine Inhaler	6	95% Confidence Interval 2 to 12	participants
Seven Day Point Abstinence From Cigarette Smoking	Varenicline With Bupropion	29	95% Confidence Interval 20 to 39	participants
Continuous Cigarette Abstinence From Quit Date	Varenicline	9	95% Confidence Interval 4 to 16	participants
Continuous Cigarette Abstinence From Quit Date	Nicotine Patches Only	13	95% Confidence Interval 7 to 20	participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow16

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Varenicline	109
Overall Study	STARTED	Nicotine Patches Only	50
Overall Study	STARTED	Nicotine Patches With Nicotine Inhaler	55
Overall Study	STARTED	Varenicline With Bupropion	113
Overall Study	Finished Treatment Phase	Varenicline	71
Overall Study	Finished Treatment Phase	Nicotine Patches Only	34
Overall Study	Finished Treatment Phase	Nicotine Patches With Nicotine Inhaler	39
Overall Study	Finished Treatment Phase	Varenicline With Bupropion	72
Overall Study	COMPLETED	Varenicline	51
Overall Study	COMPLETED	Nicotine Patches Only	25

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events100

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	Events
other	Headache	Nervous system disorders	Varenicline	10	109	12
other	Headache	Nervous system disorders	Nicotine Patches Only	5	50	5
other	Headache	Nervous system disorders	Nicotine Patches With Nicotine Inhaler	5	55	5
other	Headache	Nervous system disorders	Varenicline With Bupropion	9	113	11
other	Headache	Nervous system disorders	Dropped Prior to Condition Assignment	0	22	0
other	Nasal / Sinus Irritation	Respiratory, thoracic and mediastinal disorders	Varenicline	5	109	5
other	Nasal / Sinus Irritation	Respiratory, thoracic and mediastinal disorders	Nicotine Patches Only	4	50	5
other	Nasal / Sinus Irritation	Respiratory, thoracic and mediastinal disorders	Nicotine Patches With Nicotine Inhaler	3	55	3
other	Nasal / Sinus Irritation	Respiratory, thoracic and mediastinal disorders	Varenicline With Bupropion	7	113	7
other	Nasal / Sinus Irritation	Respiratory, thoracic and mediastinal disorders	Dropped Prior to Condition Assignment	0	22	0

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varenicline
Total, all-cause mortality	Nicotine Patches Only
Total, all-cause mortality	Nicotine Patches With Nicotine Inhaler
Total, all-cause mortality	Varenicline With Bupropion
Total, all-cause mortality	Dropped Prior to Condition Assignment
Total, other adverse events	Varenicline	76	109
Total, other adverse events	Nicotine Patches Only	33	50
Total, other adverse events	Nicotine Patches With Nicotine Inhaler	38	55
Total, other adverse events	Varenicline With Bupropion	80	113
Total, other adverse events	Dropped Prior to Condition Assignment	0	22

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24934962	DERIVED	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
P50DA027840	Center for Adaptive Treatment of Cigarette Addiction	ROSE, JED E	DUKE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2010 to 2019

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT01303861

GET https://conductscience.org/api/trials/v1/NCT01303861/events?page=2

API reference For AI assistants