Know Cancer

or
forgot password

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
Open (Enrolling)
Both
Smoking Cessation

Thank you

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