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
Phase 4
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Smoking Cessation
Both
Smoking Cessation
Trial Information
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
Inclusion Criteria:
- Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and
considered suitable for a smoking cessation attempt.
- Smoked an average of at least 10 cigarettes per day during past year and during the
month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at
screening.
- For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in
protocol.
Exclusion Criteria:
- Subjects with a past or current diagnosis of one of the following disorders:
a. Psychotic Disorders:
- Schizophreniform
- Delusional Disorder
- Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive
Disorders c. All Substance Induced Disorders (Other than nicotine)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
At least 1 severe AE of anxiety depression, feeling abnormal, or hostility and/or moderate or severe AE of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation/behavior/completed
Outcome Time Frame:
Week 12
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A3051123
NCT ID:
NCT01456936
Start Date:
November 2011
Completion Date:
October 2016
Related Keywords:
- Smoking Cessation
- smoking cessation
- psychiatric disease
- Mental Disorders
- Smoking
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Renstar Medical Research | Ocala, Florida 34474 |
| Oregon Health and Sciences University | Portland, Oregon |
| The University of Texas M.D. Anderson Cancer Center | Houston, Texas |
| Clinical Research Associates, Inc. | Nashville, Tennessee 37203 |
| Heartland Research Associates, LLC | Wichita, Kansas 67207 |
| Volunteer Research Group | Knoxville, Tennessee 37920 |
| Jacksonville Center for Clinical Research | Jacksonville, Florida 32216 |
| American Health Network of IN, LLC | Indianapolis, Indiana 46237 |
| University of Wisconsin School of Medicine and Public Health | Madison, Wisconsin 53792-5666 |
| Clinical Research Associates of Tidewater | Norfolk, Virginia 23507 |
| Clinical Research Atlanta | Stockbridge, Georgia 30281 |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary, North Carolina 27518 |
| Broward Research Group | Pembroke Pines, Florida 33026 |
| Advanced Clinical Research | Meridian, Idaho 83642 |
| Central Kentucky Research Associates, Inc. | Mount Sterling, Kentucky 40353 |
| Wake Research Associates, LLC | Raleigh, North Carolina 27612 |
| Coastal Carolina Research Center | Mt. Pleasant, South Carolina 29464 |
| Coastal Clinical Research, Inc. | Mobile, Alabama 36608 |
| Synergy Clinical Research of Escondido | Escondido, California 92025 |
| Sun Valley Research Center | Imperial, California 92251 |
| Omega Clinical Trials | La Habra, California 90631 |
| David Geffen School of Medicine at University of California, Los Angeles | Los Angeles, California 90095 |
| North County Clinical Research | Oceanside, California 92056 |
| Neuropsychiatric Research Center of Orange County | Santa Ana, California 92701 |
| University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness Program | Aurora, Colorado 80045 |
| Western Affiliated Research Institute | Denver, Colorado 80209 |
| Neuropsychiatric Research Center of Southwest Florida | Fort Myers, Florida 33912 |
| Ocala Psychiatric Associates | Ocala, Florida 34474 |
| Northwest Neurobehavioral Health | Meridian, Idaho 83642 |
| AMR-Baber Research Inc. | Naperville, Illinois 60563 |
| Davis Clinic, Inc | Indianapolis, Indiana 46260 |
| Davis Clinic, Inc. | Indianapolis, Indiana 46250 |
| Kentucky Research Group | Louisville, Kentucky 40217 |
| The Center for Sexual Health | Metairie, Louisiana 70002 |
| Maine Research Associates | Auburn, Maine 04210 |
| Community Clinical Services | Lewiston, Maine 04240 |
| Milford Emergency Associates, Incorporated | Milford, Massachusetts 01757 |
| University of Minnesota- TC | Minneapolis, Minnesota 55414 |
| Precise Research Centers | Flowood, Mississippi 39232 |
| The Center for Pharmaceutical Research, PC | Kansas City, Missouri 64114 |
| Timothy R. Smith, M.D. | 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 | Princeton, New Jersey 08540 |
| Social Psychiatry Research Institute | Brooklyn, New York 11235 |
| Regional Clinical Research, Inc. | Endwell, New York 13760 |
| Wake Internal Medicine Consultants, Inc | Raleigh, North Carolina 27612 |
| Midwest Clinical Research Center | Dayton, Ohio 45417 |
| Southeastern PA Medical Institute | Broomall, Pennsylvania 19008 |
| Belmont Center for Comprehensive Treatment | Philadelphia, Pennsylvania 19131 |
| CRI Worldwide, LLC | Philadelphia, Pennsylvania 19139 |
| Lincoln Research | Lincoln, Rhode Island 02865 |
| New Orleans Center for Clinical Research | Knoxville, Tennessee 37920 |
| InSite Clinical Research | DeSoto, Texas 75115 |
| Vince and Associates Clinical Research Inc. | Overland Park, Kansas 66212 |
| Massachusetts General Hospital Pharmacy Department | Boston, Massachusetts 02114 |
