Trial · NCT01456936
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
NCT01456936, Phase 4, Completed, Pfizer; results first posted 2016-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders. Trials, record NCT01456936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01456936
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
- NCT number
- NCT01456936
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 8,144 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- Placebo, varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
- First posted
- 2011-10-21
- Last updated
- 2016-06-10
- Other registries' IDs
- eudract:2010-022914-15
- Results first posted
- 2016-05-02
- Limitations and caveats
After database lock and unblinding, one additional participant in the NRT arm of psychiatric cohort was found who had a primary endpoint event (moderate suicidal ideation) which required hospitalization; this event is not included in any analyses.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. |
| Primary | Estimated NPS AE Rate (%), by Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis. |
| Secondary | Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below. |
| Secondary | Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below. |
| Secondary | Occurrence of the Components of NPS AE Primary Endpoint (Overall) | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below. |
| Secondary | Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint. |
| Secondary | Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint. |
| Secondary | Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint. |
| Secondary | Occurrence of the Components of Severe-only NPS AE Endpoint (Overall) | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The NPS AE endpoint was the occurrence of at least 1 treatment-emergent "severe" AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent "severe" AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort | Baseline to Week 24 | The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | percentage of participants | NUMBER |
| PRIMARY | Estimated NPS AE Rate (%), by Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | participants | NUMBER |
| SECONDARY | Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | participants | NUMBER |
| SECONDARY | Occurrence of the Components of NPS AE Primary Endpoint (Overall) | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | participants | NUMBER |
| SECONDARY | Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | percentage of participants | NUMBER |
| SECONDARY | Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | participants | NUMBER |
| SECONDARY | Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | participants | NUMBER |
| SECONDARY | Occurrence of the Components of Severe-only NPS AE Endpoint (Overall) | Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | participants | NUMBER |
| SECONDARY | Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort | Baseline to Week 24 | The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints. | Units on a scale | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group1,008
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Varenicline 1.0 mg BID | Non-psychiatric cohort (N= 990, 989, 1006, 999) | 1.3 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Bupropion 150 mg BID | Non-psychiatric cohort (N= 990, 989, 1006, 999) | 2.2 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | NRT Patch | Non-psychiatric cohort (N= 990, 989, 1006, 999) | 2.5 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Placebo | Non-psychiatric cohort (N= 990, 989, 1006, 999) | 2.4 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Varenicline 1.0 mg BID | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | 6.5 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Bupropion 150 mg BID | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | 6.7 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | NRT Patch | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | 5.2 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Placebo | Psychiatric cohort (N= 1026, 1017, 1016, 1015) | 4.9 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Varenicline 1.0 mg BID | Overall (N= 2016, 2006, 2022, 2014) | 4.0 | percentage of participants | |
| Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | Bupropion 150 mg BID | Overall (N= 2016, 2006, 2022, 2014) | 4.5 | percentage of participants |
1 to 10 of 1,008Source ClinicalTrials.gov
See all 1,008 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 2,037 | |
| Overall Study | STARTED | Bupropion | 2,034 | |
| Overall Study | STARTED | NRT Patch | 2,038 | |
| Overall Study | STARTED | Placebo | 2,035 | |
| Overall Study | Randomized and Treated | Varenicline | 2,016 | |
| Overall Study | Randomized and Treated | Bupropion | 2,006 | |
| Overall Study | Randomized and Treated | NRT Patch | 2,022 | |
| Overall Study | Randomized and Treated | Placebo | 2,014 | |
| Overall Study | COMPLETED | Varenicline | 1,598 | |
| Overall Study | COMPLETED | Bupropion | 1,586 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events612
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 | Dry mouth | Gastrointestinal disorders | Varenicline 1.0 mg BID | 66 | 2,016 | |
| other | Dry mouth | Gastrointestinal disorders | Bupropion | 146 | 2,006 | |
| other | Dry mouth | Gastrointestinal disorders | NRT Patch | 59 | 2,022 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 64 | 2,014 | |
| other | Nausea | Gastrointestinal disorders | Varenicline 1.0 mg BID | 511 | 2,016 | |
| other | Nausea | Gastrointestinal disorders | Bupropion | 201 | 2,006 | |
| other | Nausea | Gastrointestinal disorders | NRT Patch | 199 | 2,022 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 137 | 2,014 | |
| other | Application site pruritus | General disorders | Varenicline 1.0 mg BID | 22 | 2,016 | |
| other | Application site pruritus | General disorders | Bupropion | 12 | 2,006 |
1 to 10 of 612Source ClinicalTrials.gov
See all 612 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline 1.0 mg BID | ||
| Total, all-cause mortality | Bupropion | ||
| Total, all-cause mortality | NRT Patch | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Varenicline 1.0 mg BID | 1,158 | 2,016 |
| Total, other adverse events | Bupropion | 1,033 | 2,006 |
| Total, other adverse events | NRT Patch | 1,003 | 2,022 |
| Total, other adverse events | Placebo | 884 | 2,014 |
| Total, serious adverse events | Varenicline 1.0 mg BID | 39 | 2,016 |
| Total, serious adverse events | Bupropion | 48 | 2,006 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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.
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/NCT01456936
GET https://conductscience.org/api/trials/v1/NCT01456936/registered?page=2