Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Public ClinicalTrials.gov record NCT01456936. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01456936
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 8,144 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- varenicline tartrate Drug
- bupropion hydrochloride Drug
- Nicotine Replacement Therapy Patch Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2011 (Type not available)
- Primary completion
- Jan 2015 (Actual)
- Completion
- Jan 2015 (Actual)
- Last update posted
- Jun 10, 2016
2011 – 2015
United States locations
- U.S. sites
- 77
- U.S. states
- 30
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| NoesisPharma Research | Phoenix | Arizona | 85032 | — |
| Pharmacology Research Institute | Encino | California | 91316 | — |
| Synergy Clinical Research of Escondido | Escondido | California | 92025 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Omega Clinical Trials | La Habra | California | 90631 | — |
| Pacific Treatment and Research Center UC San Diego Health System | La Jolla | California | 92037 | — |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | — |
| David Geffen School of Medicine at University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Pharmacology Research Institute | Newport Beach | California | 92660 | — |
| North County Clinical Research | Oceanside | California | 92056 | — |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | — |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | — |
| University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program | Aurora | Colorado | 80045 | — |
| Western Affiliated Research Institute | Denver | Colorado | 80209 | — |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | — |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers | Florida | 33912 | — |
| Broward Research Group | Hollywood | Florida | 33024 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Clinical Neuroscience Solutions,Inc. | Jacksonville | Florida | 32256 | — |
| Meridien Research | Lakeland | Florida | 33805 | — |
| Renstar Medical Research | Ocala | Florida | 34471 | — |
| Ocala Psychiatric Associates | Ocala | Florida | 34474 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | — |
| Meridien Research | Tampa | Florida | 33634 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Northwest Neurobehavioral Health | Meridian | Idaho | 83642 | — |
| AMR-Baber Research Inc. | Naperville | Illinois | 60563 | — |
| American Health Network of IN, LLC | Indianaopolis | Indiana | 46254 | — |
| Davis Clinic, Incorporated | Indianapolis | Indiana | 46250 | — |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | — |
| Kentucky Research Group | Louisville | Kentucky | 40218 | — |
| A Professional Corporation dba The Center for Sexual Health | Metairie | Louisiana | 70002 | — |
| Maine Research Associates | Auburn | Maine | 04210 | — |
| Community Clinical Services | Lewiston | Maine | 04240 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Milford Emergency Associates, Incorporated | Milford | Massachusetts | 01757 | — |
| Rahim Shafa, MD | Milford | Massachusetts | 01757 | — |
| University of Minnesota- TC | Minneapolis | Minnesota | 55414 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| The Center for Pharmaceutical Research, PC | Kansas City | Missouri | 64114 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Global Medical Institutes LLC; Princeton Medical Institute Woodlands Professional Building | Princeton | New Jersey | 08540 | — |
| Social Psychiatry Research Institute Clinical Trials LLC | Brooklyn | New York | 11235 | — |
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | — |
| Tooley Group | Cary | North Carolina | 27511 | — |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | 27518 | — |
| Wake Internal Medicine Consultants, Inc | Raleigh | North Carolina | 27612 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239-3098 | — |
| Southeastern PA Medical Institute | Broomall | Pennsylvania | 19008 | — |
| Belmont Center for Comprehensive Treatment | Philadelphia | Pennsylvania | 19131 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| East Side Clinical Laboratory | Lincoln | Rhode Island | 02865 | — |
| Lincoln Research | Lincoln | Rhode Island | 02865 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | — |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | — |
| Clinical NeuroScience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | — |
| James G. Kyser, MD | Nashville | Tennessee | 37203 | — |
| FutureSearch Clinical Trials, L.P. | Austin | Texas | 78731 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77230-1439 | — |
| Peninsula Psychotherapy Center, LLC | Newport News | Virginia | 23606 | — |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | — |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53711-2027 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01456936, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2016 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01456936 live on ClinicalTrials.gov.