Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01456936 · ClinicalTrials.gov registry record · Phase 4
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 8,144
- Enrollment target
NCT01456936: Completed Phase 4 study, sponsored by Pfizer.
NCT01456936 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 8,144 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1472% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456936, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8,144 participants
- Enrollment target
Study Summary
This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Nicotine Replacement Therapy Patch
- DRUG bupropion hydrochloride
- DRUG varenicline tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,144 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 4 |
What the finished NCT01456936 record still lists
NCT01456936 is an interventional study that assigns participants to a tested intervention. Its 8,144 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1472% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01456936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01456936 about?
NCT01456936 is a clinical study titled "Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders". This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these po...
What is the current status of trial NCT01456936?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8,144 participants. The study started on 2011-11. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01456936?
The interventions under investigation include: Placebo (DRUG), Nicotine Replacement Therapy Patch (DRUG), bupropion hydrochloride (DRUG), varenicline tartrate (DRUG).
Who is sponsoring clinical trial NCT01456936?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01456936's enrollment target sits among peer trials
8,144 10th of 2000 higher than 1,991 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06184945 · 8,100 participants · NA
Behavioral Economic & Staffing Strategies in the ICU
- NCT06435806 · 8,200 participants · NA
Medical Illustration Design Characteristic Evaluation
- NCT05593484 · 8,060 participants · NA
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska
- NCT07185828 · 8,286 participants · NA
Informing Low-acuity Emergency Department Patients of Non-emergent Resources (2)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia