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 ClinicRochester, Minnesota  55905
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Mayo ClinicJacksonville, Florida  32224
Renstar Medical ResearchOcala, Florida  34474
Oregon Health and Sciences UniversityPortland, Oregon  
The University of Texas M.D. Anderson Cancer CenterHouston, Texas  
Clinical Research Associates, Inc.Nashville, Tennessee  37203
Heartland Research Associates, LLCWichita, Kansas  67207
Volunteer Research GroupKnoxville, Tennessee  37920
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
American Health Network of IN, LLCIndianapolis, Indiana  46237
University of Wisconsin School of Medicine and Public HealthMadison, Wisconsin  53792-5666
Clinical Research Associates of TidewaterNorfolk, Virginia  23507
Clinical Research AtlantaStockbridge, Georgia  30281
PMG Research of Raleigh, LLC d/b/a PMG Research of CaryCary, North Carolina  27518
Broward Research GroupPembroke Pines, Florida  33026
Advanced Clinical ResearchMeridian, Idaho  83642
Central Kentucky Research Associates, Inc.Mount Sterling, Kentucky  40353
Wake Research Associates, LLCRaleigh, North Carolina  27612
Coastal Carolina Research CenterMt. Pleasant, South Carolina  29464
Coastal Clinical Research, Inc.Mobile, Alabama  36608
Synergy Clinical Research of EscondidoEscondido, California  92025
Sun Valley Research CenterImperial, California  92251
Omega Clinical TrialsLa Habra, California  90631
David Geffen School of Medicine at University of California, Los AngelesLos Angeles, California  90095
North County Clinical ResearchOceanside, California  92056
Neuropsychiatric Research Center of Orange CountySanta Ana, California  92701
University of Colorado Denver, Anschutz Medical Campus , Behavioral Health and Wellness ProgramAurora, Colorado  80045
Western Affiliated Research InstituteDenver, Colorado  80209
Neuropsychiatric Research Center of Southwest FloridaFort Myers, Florida  33912
Ocala Psychiatric AssociatesOcala, Florida  34474
Northwest Neurobehavioral HealthMeridian, Idaho  83642
AMR-Baber Research Inc.Naperville, Illinois  60563
Davis Clinic, IncIndianapolis, Indiana  46260
Davis Clinic, Inc.Indianapolis, Indiana  46250
Kentucky Research GroupLouisville, Kentucky  40217
The Center for Sexual HealthMetairie, Louisiana  70002
Maine Research AssociatesAuburn, Maine  04210
Community Clinical ServicesLewiston, Maine  04240
Milford Emergency Associates, IncorporatedMilford, Massachusetts  01757
University of Minnesota- TCMinneapolis, Minnesota  55414
Precise Research CentersFlowood, Mississippi  39232
The Center for Pharmaceutical Research, PCKansas City, Missouri  64114
Timothy R. Smith, M.D.St.Louis, Missouri  63141
University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08901
Global Medical Institutes LLC; Princeton Medical InstitutePrinceton, New Jersey  08540
Social Psychiatry Research InstituteBrooklyn, New York  11235
Regional Clinical Research, Inc.Endwell, New York  13760
Wake Internal Medicine Consultants, IncRaleigh, North Carolina  27612
Midwest Clinical Research CenterDayton, Ohio  45417
Southeastern PA Medical InstituteBroomall, Pennsylvania  19008
Belmont Center for Comprehensive TreatmentPhiladelphia, Pennsylvania  19131
CRI Worldwide, LLCPhiladelphia, Pennsylvania  19139
Lincoln ResearchLincoln, Rhode Island  02865
New Orleans Center for Clinical ResearchKnoxville, Tennessee  37920
InSite Clinical ResearchDeSoto, Texas  75115
Vince and Associates Clinical Research Inc.Overland Park, Kansas  66212
Massachusetts General Hospital Pharmacy DepartmentBoston, Massachusetts  02114