Clinical Trials

Varenicline tartrate has been extensively evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, underscoring its essential role in addiction medicine. Sponsored by major academic institutions and commercial entities, these studies target primary indications such as nicotine dependence, tobacco use disorder, and smoking cessation, along with secondary conditions like cocaine dependence, chronic obstructive pulmonary disease, and attention deficit/hyperactivity disorder. Although most protocols are completed, active and recruiting studies continue to investigate adjunctive therapeutic strategies to enhance smoking cessation success rates.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07783555 NOT_YET_RECRUITING
Cannabis Abuse
Medical University of South Carolina
 2026-12-01 PHASE2
NCT07040566 RECRUITING
E-cigarette Use; Vaping; Nicotine Dependence
Yale University
 2025-10-14 PHASE2
NCT06966362 RECRUITING
Veterans; Tobacco Use Disorder; Cigarette Smoking; Tobacco Dependence
VA Office of Research and Development
 2026-08-17 PHASE4
NCT07714200 NOT_YET_RECRUITING
Tobacco Use Disorder
VA Office of Research and Development
 2027-03-01
NCT07099638 RECRUITING
Smoking Cessation
University of Oklahoma
 2026-07-21 PHASE2
NCT06609369 RECRUITING
Tobacco Use; Tobacco Cessation; Insomnia
Yale University
 2025-04-21 PHASE2
NCT03630614 ACTIVE_NOT_RECRUITING
Smoking Cessation; Smoking, Cigarette; Electronic Cigarette
Assistance Publique - Hôpitaux de Paris
 2018-10-17 PHASE3
NCT07596485 RECRUITING
Trigeminal Neuralgia
Kriya Therapeutics, Inc.
 2026-08 PHASE1; PHASE2
NCT06679374 RECRUITING
Parkinson Disease
Vikas Kotagal
 2025-04-09 PHASE2
NCT04604509 RECRUITING
Cigarette Smoking-Related Carcinoma
M.D. Anderson Cancer Center
 2020-08-04 PHASE4
NCT06751927 RECRUITING
Smoking Cessation
University of Chicago
 2025-04-24
NCT06883162 RECRUITING
Tobacco Use Disorder; Tobacco Use Cessation; Cannabis Use; Cannabis Use Disorder; Marijuana Use
Medical University of South Carolina
 2025-05-06 PHASE3
NCT06582888 RECRUITING
Nicotine Addiction; Craving
University of California, San Diego
 2024-11-19 EARLY_PHASE1
NCT06474299 RECRUITING
Smoking Cessation; Electronic Cigarette Use
University of Wisconsin, Madison
 2024-09-24 PHASE4
NCT02162849 ACTIVE_NOT_RECRUITING
Tobacco Use Cessation
M.D. Anderson Cancer Center
 2015-12-14 PHASE4
NCT06798324 RECRUITING
Nicotine Dependence; Tobacco Smoking; Smoking Cessation; Nicotine Use Disorder; Tobacco Use Disorder; Substance Use Disorders
Centre for Addiction and Mental Health
 2025-03-10 PHASE4
NCT01098955 ACTIVE_NOT_RECRUITING
Head and Neck Cancer; Smoking Cessation
M.D. Anderson Cancer Center
 2010-03-24 EARLY_PHASE1
NCT07145866 RECRUITING
Nicotine Dependence; Transcranial Magnetic Stimulation; Vaping; Smoking Cessation; Smoking (Tobacco) Addiction
Massachusetts General Hospital
 2026-08 PHASE4
NCT05413122 RECRUITING
Smoking Cessation; HIV; Comorbidities and Coexisting Conditions
Johns Hopkins University
 2023-11-27 PHASE2; PHASE3
NCT06832085 RECRUITING
Tobacco
Ottawa Heart Institute Research Corporation
 2025-04-30 PHASE4
NCT06688539 RECRUITING
Nicotine Dependence; Tobacco Use Disorder
Medical University of South Carolina
 2025-02-19 PHASE4
NCT05642715 RECRUITING
Hiv; Tobacco Use
Montefiore Medical Center
 2024-04-04
NCT05694637 ENROLLING_BY_INVITATION
Smoking Cessation; Hiv
University of Maryland, Baltimore
 2023-07-25 PHASE4
NCT07606625 RECRUITING
Dry Eye; Meibomian Gland Dysfunction
University of California, Berkeley
 2026-03-06 PHASE4
NCT05703672 RECRUITING
Smoking Reduction
University of Kansas Medical Center
 2023-07-17 PHASE3
NCT07705893 RECRUITING
Dry Eye
Ocular Aesthetics, LLC dba Ocular Clinical Trials
 2026-07-28
NCT04176172 ACTIVE_NOT_RECRUITING
HIV/AIDS; Nicotine Dependence
Abramson Cancer Center at Penn Medicine
 2020-02-17 PHASE3
NCT06006143 ACTIVE_NOT_RECRUITING
Alcohol Use Disorder; Hiv; Tobacco Use Disorder
Yale University
 2025-06-16 PHASE2
NCT05786547 RECRUITING
Human Immunodeficiency Virus; Smoking Cessation; Smoking, Tobacco
University of Colorado, Denver
 2024-01-02 PHASE3
NCT07171112 WITHDRAWN
Pancreatitis, Chronic; Pancreatitis, Acute; Recurrent Acute Pancreatitis; Smoking (Tobacco) Addiction
Mayo Clinic
 2025-11-06 PHASE2
NCT05257629 RECRUITING
Acute Coronary Syndrome; Cardiovascular Diseases
Sir Mortimer B. Davis - Jewish General Hospital
 2023-02-02 PHASE3
NCT04634071 COMPLETED
Smoking Cessation; Cancer, Treatment-Related
Joseph Valentino, MD
 2021-01-12 PHASE2
NCT06854406 COMPLETED
Irritable Bowel Syndrome
Mayo Clinic
 2025-06-01 PHASE1
NCT06027840 COMPLETED
Cigarette Smoking; E-Cigarette Use; Smoking Cessation
Yale University
 2024-04-01 PHASE1
NCT05997225 COMPLETED
Tobacco Use; Tobacco Smoking; Tobacco Use Cessation
Albert Einstein College of Medicine
 2024-05-31 PHASE4
NCT04725617 RECRUITING
HIV; Sleep; Smoking Cessation; Cardiovascular Diseases
University of Arizona
 2021-11-16
NCT06780215 COMPLETED
Premature Ventricular Contraction (PVC)
Yihan Chen
 2025-02-17 PHASE2
NCT06029907 COMPLETED
Smoking Cessation; Pain
Duke University
 2024-07-15 PHASE4
NCT06218823 COMPLETED
Smoking Cessation; Cancer
University of Wisconsin, Madison
 2024-03-01 PHASE4
NCT02271919 COMPLETED
Cigarette Smoker; Tobacco Use Disorder
M.D. Anderson Cancer Center
 2015-05-14 PHASE4
NCT04188873 COMPLETED
Nicotine Dependence
University of Wisconsin, Madison
 2020-12-10 PHASE4
NCT04198116 COMPLETED
Smoking Cessation
Yale University
 2020-11-01 PHASE2
NCT05997901 COMPLETED
Medication Adherence; Smoking Cessation
Centre for Addiction and Mental Health
 2024-06-01
NCT04525755 COMPLETED
Smoking; Smoking Cessation; Tobacco Smoking; Cigarette Smoking
Medical University of South Carolina
 2021-02-08 PHASE1; PHASE2
NCT04490057 COMPLETED
Tobacco Use Cessation
Yale University
 2020-07-27 PHASE4
NCT04199117 COMPLETED
Smoking, Cigarette; Smoking Cessation
University of Wisconsin, Madison
 2020-03-11 PHASE4
NCT04694846 COMPLETED
Lung Non-Small Cell Carcinoma; Head and Neck Squamous Cell Carcinoma
Thomas Jefferson University
 2020-08-19
NCT04445662 COMPLETED
Tobacco Smoking
Massachusetts General Hospital
 2021-06-10
NCT05294263 WITHDRAWN
Tobacco Use Disorder; Cannabis Use Disorder
VA Office of Research and Development
 2023-04-17 PHASE2
NCT04228965 COMPLETED
Tobacco Use Disorder
Medical University of South Carolina
 2020-01-28 PHASE4
NCT04590404 COMPLETED
Smoking
Vanderbilt-Ingram Cancer Center
 2020-11-17 PHASE3
NCT05367492 COMPLETED
Vaping; Nicotine Dependence
Massachusetts General Hospital
 2022-06-22 PHASE4
NCT04738643 COMPLETED
Cancer; Tobacco Use; Smoking; Nicotine Dependence
Abramson Cancer Center at Penn Medicine
 2022-06-28
NCT05514041 COMPLETED
Dry Eye Disease
Stephenson Eye Associates
 2022-10-11 PHASE4
NCT03365362 COMPLETED
Tobacco Use Disorder; Opioid-use Disorder
Albert Einstein College of Medicine
 2018-10-25 PHASE4
NCT03059563 TERMINATED
Dopamine D2/3 Receptor Availability; Cognitive Function; Methamphetamine Abuse
University of California, Los Angeles
 2018-01-11 PHASE1
NCT05541497 COMPLETED
Smoking Cessation
Yale University
 2022-11-04 PHASE2
NCT05700422 COMPLETED
Sjogren's Syndrome; Dry Eye
University of Pennsylvania
 2023-05-01 PHASE4
NCT05576415 COMPLETED
Dry Eye Disease
Corxel Pharmaceuticals
 2022-12-07 PHASE1
NCT05378945 COMPLETED
Dry Eye Disease
Corxel Pharmaceuticals
 2022-07-22 PHASE3
NCT03980561 COMPLETED
Cannabis Use Disorder
Medical University of South Carolina
 2020-01-31 PHASE2
NCT04317300 WITHDRAWN
Vaping
Mayo Clinic
 2023-02-01 EARLY_PHASE1
NCT04957758 COMPLETED
Neurotrophic Keratopathy
Oyster Point Pharma, Inc.
 2021-06-17 PHASE2
NCT04167306 COMPLETED
Alcohol Use Disorder; Alcoholism; Alcohol Dependence
Vastra Gotaland Region
 2019-03-04 PHASE2
NCT04015414 COMPLETED
Smoking Cessation
University of Zagreb
 2020-07-14 PHASE3
NCT04083144 COMPLETED
Tobacco Use Disorder; Smoking Cessation
Centre for Addiction and Mental Health
 2019-08-22
NCT03497299 WITHDRAWN
Tobacco Use Disorder; Schizophrenia; Cognitive Functioning; Craving
Centre for Addiction and Mental Health
 2018-07-01 PHASE2
NCT05045508 UNKNOWN
Dry Eye
Brandon Baartman
 2021-08-30 PHASE3
NCT05082974 COMPLETED
Dry Eye Disease
Vance Thompson Vision ND
 2021-10-20 PHASE3
NCT05161208 COMPLETED
Dry Eye
Center for Ophthalmic and Vision Research, LLC
 2021-12-03 PHASE4
NCT04191278 WITHDRAWN
HIV/AIDS; Smoking; Smoking Cessation; HIV
Duke University
 2021-11 PHASE4
NCT04249882 COMPLETED
Alcohol Use Disorder
University of California, Los Angeles
 2020-01-28 PHASE2
NCT04602494 TERMINATED
Vaping; Nicotine Dependence
Massachusetts General Hospital
 2020-12-18 PHASE4
NCT05136924 UNKNOWN
Dry Eye Disease
Vance Thompson Vision - MT
 2021-12-01 PHASE2
NCT03557294 COMPLETED
Tobacco Dependence; Withdrawal Symptoms; Smoking Cessation
Arizona State University
 2018-05-07 PHASE4
NCT03362099 COMPLETED
Smoking Cessation; Genetic Predisposition
University of Sao Paulo General Hospital
 2016-11-01 PHASE4
NCT04011280 COMPLETED
Bipolar Disorder; Schizophrenia; Schizoaffective Disorder; Nicotine Dependence
University of California, San Diego
 2019-08-12 PHASE4
NCT03722966 TERMINATED
Smoking Cessation
University of Oklahoma
 2020-01-07 PHASE2
NCT03841292 COMPLETED
Tobacco Dependence; Smoking Cessation; Tobacco Smoking; Tobacco Use Disorder; Substance Use Disorders; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs
Centre for Addiction and Mental Health
 2018-10-01
NCT03897439 COMPLETED
Smoking Cessation
University of Kansas Medical Center
 2019-05-01 PHASE3
NCT04135937 COMPLETED
Human Immunodeficiency Virus; Smoking
VA Office of Research and Development
 2019-11-18 PHASE4
NCT02856581 TERMINATED
Lung Carcinoma
Alliance for Clinical Trials in Oncology
 2017-09-29 PHASE3
NCT03262662 COMPLETED
Tobacco Smoking
State University of New York at Buffalo
 2017-10-01 PHASE3
NCT02460900 COMPLETED
Smoking; HIV
University of Maryland, Baltimore
 2016-07 PHASE3
NCT03235505 COMPLETED
Smoking Cessation; Electronic Cigarette
University of Oulu
 2018-08-01 PHASE4
NCT02575183 COMPLETED
Nicotine Dependence
American University of Beirut Medical Center
 2016-08-31 PHASE4
NCT01926041 ACTIVE_NOT_RECRUITING
Diabetes Mellitus; Cigarette Smoking; Prediabetes
National Taiwan University Hospital
 2013-08-01
NCT02307045 UNKNOWN
Smoking Cessation
University of Athens
 2014-12-03 PHASE4
NCT04210180 COMPLETED
Smoking Cessation; Harm Reduction
Rose Research Center, LLC
 2019-11-19 PHASE2; PHASE3
NCT02859142 COMPLETED
Smoking Cessation; Alcohol Drinking
University of Chicago
 2018-03-29 PHASE4
NCT02501265 COMPLETED
Nicotine Dependence
Duke University
 2017-06-06 PHASE2
NCT03176784 COMPLETED
Tobacco Dependence
University of Wisconsin, Madison
 2017-11-11 PHASE4
NCT00943618 COMPLETED
Smoking Cessation
M.D. Anderson Cancer Center
 2010-05-17 PHASE3
NCT04631874 COMPLETED
Smoking Cessation; Pharmacokinetics
CTC Bio, Inc.
 2019-07-24 PHASE1
NCT02797587 COMPLETED
HIV Infection; Alcohol Use; Smoking
Boston Medical Center
 2017-07-19 PHASE2; PHASE3
NCT03495024 RECRUITING
Schizophrenia; Schizoaffective Disorder; Tobacco Smoking; Tardive Dyskinesia; Parkinsonism
Corporal Michael J. Crescenz VA Medical Center
 2019-01-01 PHASE4
NCT02412631 TERMINATED
Obesity; Smoking Cessation
Mayo Clinic
 2016-06-15 PHASE2; PHASE3
NCT04036292 COMPLETED
Dry Eye Disease (DED)
Oyster Point Pharma, Inc.
 2019-07-23 PHASE3
NCT03742154 COMPLETED
Smoking; Smoking Cessation; Smoking, Tobacco; Smoking, Cigarette
Medical University of South Carolina
 2018-12-03 EARLY_PHASE1
NCT03809897 WITHDRAWN
Tobacco Use Cessation; Psychiatric Disorders
Hospital Universitari Vall d'Hebron Research Institute
 2019-01 PHASE4
NCT01511614 COMPLETED
Nicotine Dependence
National Institute on Drug Abuse (NIDA)
 2013-05-20
NCT02378714 COMPLETED
Nicotine Dependence; Major Depressive Disorder
Northwestern University
 2015-07-24 PHASE4
NCT02723162 COMPLETED
Nicotine Dependence, Cigarettes
Medical University of South Carolina
 2016-05-04 PHASE2
NCT04089982 COMPLETED
Smoking Cessation; Smoking Behaviors; Smoking
Duke University
 2019-11-04 PHASE4
NCT03873246 COMPLETED
Dry Eye Disease
Oyster Point Pharma, Inc.
 2019-02-18 PHASE2
NCT00507728 COMPLETED
Tobacco Use Disorder; Smoking Cessation
M.D. Anderson Cancer Center
 2005-12-08 PHASE2; PHASE3
NCT04188106 COMPLETED
Smoking Cessation; Stress; Sleep Disturbance; Nausea
Rose Research Center, LLC
 2019-06-17 PHASE4
NCT02698215 COMPLETED
Nicotine Dependence; Alcohol Use Disorder
University of California, Los Angeles
 2016-05 PHASE2
NCT02894957 UNKNOWN
Smoking Cessation
Shaare Zedek Medical Center
 2019-10 PHASE4
NCT04072146 COMPLETED
Healthy Subjects
Oyster Point Pharma, Inc.
 2019-08-26 PHASE1
NCT03538808 COMPLETED
Medication Adherence
University of Alabama at Birmingham
 2018-11-06 PHASE4
NCT02957786 COMPLETED
Smoking Cessation
University of Auckland, New Zealand
 2017-09-18 PHASE3
NCT03688802 COMPLETED
Dry Eye Disease
Oyster Point Pharma, Inc.
 2018-09-25 PHASE2
NCT02994082 UNKNOWN
Smokeless Tobacco; Nicotine Dependence
Mark Vander Weg
 2016-12
NCT03507127 TERMINATED
Tobacco Dependence
Brown University
 2018-05-01 PHASE2
NCT04403399 COMPLETED
Parkinson's Disease
University of Michigan
 2017-06-29 PHASE2
NCT02933372 COMPLETED
Parkinson's Disease
University of Michigan
 2015-10-05 PHASE2
NCT02991781 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD); Asthma; Smoking
Aristotle University Of Thessaloniki
 2017-01
NCT02048917 COMPLETED
Lung Cancer; Head and Neck Cancer
University of Kentucky
 2014-07-22 PHASE1
NCT03521141 COMPLETED
Tobacco Use Cessation
Vanderbilt University Medical Center
 2018-05-18 PHASE2; PHASE3
NCT02551692 COMPLETED
Cigarette Smoking
Duke University
 2016-01
NCT03069768 WITHDRAWN
Nicotine Dependence
Duke University
 2018-04 PHASE1
NCT02351167 COMPLETED
Smoking Cessation
Washington University School of Medicine
 2015-05-20 PHASE4
NCT02892110 COMPLETED
Substance Use Disorder
Medical University of South Carolina
 2017-02-13 PHASE2
NCT01341080 COMPLETED
Parkinson Disease
Rush University Medical Center
 2010-12-28 PHASE2
NCT03553173 COMPLETED
Smoking Cessation; Health Behavior; Lifestyle-related Condition
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2016-10-24
NCT02582008 TERMINATED
Current Smoker; Head and Neck Squamous Cell Carcinoma; Hypopharyngeal Squamous Cell Carcinoma; Laryngeal Squamous Cell Carcinoma; Nasopharyngeal Carcinoma; Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma
Wake Forest University Health Sciences
 2016-01 EARLY_PHASE1
NCT03636061 COMPLETED
Dry Eye Disease
Oyster Point Pharma, Inc.
 2018-08-15 PHASE2
NCT01710137 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2012-10 PHASE3
NCT02106637 UNKNOWN
Acute Coronary Syndrome; Smoking Cessation
Sheba Medical Center
 2016-10
NCT03035708 COMPLETED
Alcohol Use Disorder
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2017-05-01 PHASE1; PHASE2
NCT02634281 COMPLETED
Smoking Cessation
Shaare Zedek Medical Center
 2016-02 PHASE4
NCT02151591 COMPLETED
Nicotine Dependence; Cigarette Smoking; Alcohol Consumption; Heavy Drinking
Yale University
 2017-03-01 PHASE1
NCT01756885 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2013-01 PHASE3
NCT02888444 TERMINATED
Chronic Obstructive Pulmonary Disease; Smoking Cessation
University of Auckland, New Zealand
 2017-07-31 PHASE3
NCT01509547 COMPLETED
Nicotine Dependence
Medical University of South Carolina
 2012-08 PHASE3
NCT01680887 COMPLETED
Cocaine Dependence
University of Pennsylvania
 2012-08 PHASE2
NCT02473562 TERMINATED
Parkinson's Disease
Amsterdam UMC, location VUmc
 2013-05 PHASE4
NCT01312909 COMPLETED
Smoking Cessation
Pfizer
 2011-04 PHASE4
NCT01892813 UNKNOWN
Nicotine Dependence; Tobacco Use
Mark Vander Weg
 2013-07 PHASE3
NCT01800019 UNKNOWN
HIV; Smoking Cessation
Ottawa Hospital Research Institute
 2014-01 PHASE3
NCT00921388 COMPLETED
Nicotine Dependence; Smoking Cessation
UConn Health
 2009-03
NCT02147132 TERMINATED
Cigarette Smoking; Methadone Maintenance
University of Cincinnati
 2016-03 PHASE4
NCT02683161 TERMINATED
Cigarette Smoking; Obesity
Johns Hopkins University
 2015-10 PHASE2
NCT04018378 COMPLETED
Healthy
Korea University Anam Hospital
 2017-01-06 PHASE1
NCT02854800 COMPLETED
Smoking Cessation; Opioid Related Disorders
West Virginia University
 2016-07-08 PHASE2; PHASE3
NCT01836276 COMPLETED
Smoking Cessation
Nikki Nollen, PhD, MA
 2013-02 PHASE4
NCT02146911 COMPLETED
Tobacco Use Disorder; Nicotine Dependence
Centre for Addiction and Mental Health
 2014-05-01
NCT02562521 COMPLETED
Smoking Cessation
Yale University
 2015-09 PHASE4
NCT00580645 COMPLETED
Alcohol Drinking
Yale University
 2007-04 PHASE2
NCT01000987 COMPLETED
Alcohol Reactivity
Yale University
 2009-10 PHASE2
NCT00773422 COMPLETED
Smoking
Yale University
 2008-01 PHASE2
NCT03227679 COMPLETED
Tobacco Use; Tobacco Use Cessation
Vanderbilt University Medical Center
 2016-05-18
NCT00580853 COMPLETED
Smoking Lapse Behavior
Yale University
 2007-04 PHASE2
NCT01093365 COMPLETED
Schizophrenia; Schizoaffective Disorder
Centre for Addiction and Mental Health
 2010-03 PHASE2
NCT02488889 WITHDRAWN
Cigarette Smoking; Alcohol Consumption
University of California, Los Angeles
 2015-08 PHASE4
NCT02681510 COMPLETED
Smoking
University of Wisconsin, Madison
 2016-02 PHASE4
NCT01162239 COMPLETED
Nicotine Dependence
University of California, San Francisco
 2010-05 PHASE3
NCT01553136 COMPLETED
Alcoholism; Alcohol Abuse; Smoking; Alcohol Drinking
Yale University
 2012-09 PHASE2
NCT02136498 COMPLETED
Smoking Cessation; Medication Adherence
Kaiser Permanente
 2014-10
NCT01531049 COMPLETED
Smoking Cessation; Smoking; Habits
Tuula Toljamo
 2012-05 PHASE2; PHASE3
NCT02202499 COMPLETED
Smoking Cessation; Tobacco Dependence
H. Lee Moffitt Cancer Center and Research Institute
 2014-07-17 EARLY_PHASE1
NCT01308671 UNKNOWN
Coronary Artery Disease
General Hospital of Chinese Armed Police Forces
 2010-10
NCT00937235 COMPLETED
Cigarette Smoking; Nicotine Dependence; Post-traumatic Stress Disorder; Tobacco Use Disorder
University of Pennsylvania
 2009-01 PHASE2
NCT01387425 COMPLETED
Smoking Cessation; Diabetes
University of Catania
 2011-06
NCT02393547 COMPLETED
Tobacco Use Disorder; Weight Gain
Mayo Clinic
 2013-09 PHASE1; PHASE2
NCT01639560 COMPLETED
Smoking
Mayo Clinic
 2013-01 PHASE4
NCT01694732 COMPLETED
Chronic Obstructive Pulmonary Disease; COPD Exacerbation; Smoking
University Hospital, Brest
 2012-08 PHASE3
NCT01524627 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2011-12 PHASE2
NCT01553084 COMPLETED
Smoking Cessation; Smoking; Nicotine Dependence
University of Wisconsin, Madison
 2012-05 PHASE4
NCT02367391 COMPLETED
Nicotine Dependence, Cigarettes
Milton S. Hershey Medical Center
 2015-01
NCT01632189 COMPLETED
Nicotine Dependence
Centre for Addiction and Mental Health
 2012-09
NCT01934023 COMPLETED
Schizophrenia
Centre for Addiction and Mental Health
 2013-09 PHASE2
NCT04595318 COMPLETED
Cannabis Dependence; Tobacco Dependence
Albert Einstein College of Medicine
 2015-01 PHASE4
NCT01378858 COMPLETED
Tobacco Use Disorder; Medication Adherence
Albert Einstein College of Medicine
 2011-07
NCT01574703 COMPLETED
Smoking Cessation
Pfizer
 2012-05 PHASE4
NCT00794573 COMPLETED
Acute Coronary Syndrome
Mark Eisenberg
 2009-09 PHASE3
NCT02922387 COMPLETED
Pulmonary Disease, Chronic Obstructive; Asthma; Community Acquired Pneumonia
General Hospital of Kavala
 2012-05 PHASE4
NCT01850953 COMPLETED
Craving; Smoking; Schizophrenia
Centre for Addiction and Mental Health
 2013-06 PHASE4
NCT01330043 COMPLETED
Smoking Cessation
Stanford University
 2010-03 PHASE4
NCT01228175 COMPLETED
Smoking Addiction
The Mind Research Network
 2010-03 PHASE4
NCT01456936 COMPLETED
Smoking Cessation
Pfizer
 2011-11 PHASE4
NCT02193256 COMPLETED
Cigarette Smoking; Alcohol Use Disorders
Yale University
 2014-07 EARLY_PHASE1
NCT01898195 COMPLETED
Tobacco Use Cessation
NYU Langone Health
 2013-03
NCT01806779 COMPLETED
Nicotine Dependence
Duke University
 2013-03 PHASE2
NCT01309685 WITHDRAWN
Drug Addiction
National Institute on Drug Abuse (NIDA)
 2011-02-13 PHASE1
NCT01413516 COMPLETED
Smoking Cessation
Stanford University
 2011-08 PHASE2
NCT01771627 COMPLETED
Tobacco Use Disorder
Roswell Park Cancer Institute
 2012-10-22
NCT01286584 COMPLETED
Smoking Cessation; Alcohol Abuse
Centre for Addiction and Mental Health
 2011-06 PHASE4
NCT00879177 COMPLETED
Cigarette Smoking; Hypertension
UConn Health
 2009-04 PHASE4
NCT01365819 COMPLETED
Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse
University of California, Los Angeles
 2012-02 PHASE2
NCT00695500 COMPLETED
Alcohol Drinking
Vijay Ramchandani, Ph.D.
 2008-06 PHASE1; PHASE2
NCT01685996 COMPLETED
Nicotine Dependence
Johns Hopkins University
 2012-09 PHASE1; PHASE2
NCT00756275 COMPLETED
Smoking Cessation; Nicotine Dependence
Brown University
 2009-01
NCT02744417 COMPLETED
Periodontitis
Claudio Mendes Pannuti
 2010-08
NCT01308736 COMPLETED
Tobacco Use Disorder
Rutgers, The State University of New Jersey
 2011-01
NCT01347112 COMPLETED
Smoking; Tobacco Dependence; Alcohol Dependence
Mayo Clinic
 2011-06 PHASE2; PHASE3
NCT01772641 TERMINATED
Nicotine Addiction
Icahn School of Medicine at Mount Sinai
 2012-12 PHASE4
NCT00918307 COMPLETED
HIV Infections; Tobacco Dependence
ANRS, Emerging Infectious Diseases
 2009-10 PHASE3
NCT00664755 COMPLETED
Nicotine Dependence
Medical University of South Carolina
 2007-07 PHASE2
NCT00895557 WITHDRAWN
Varenicline and the Blunting of Cocaine Cues
University of Pennsylvania
 2007-12 PHASE2
NCT00802919 COMPLETED
Schizophrenia; Cigarette Smoking
Nathan Kline Institute for Psychiatric Research
 2008-09 PHASE4
NCT01406223 COMPLETED
Nicotine Dependence
Duke University
 2011-07 PHASE3
NCT01314001 COMPLETED
Nicotine Addiction
University of Pennsylvania
 2010-12 PHASE3
NCT01624428 COMPLETED
Tobacco Use Disorders
Yale University
 2012-06 PHASE1
NCT01143857 WITHDRAWN
Cocaine Dependence
Jennifer Plebani
 2010-06 PHASE2
NCT01151813 COMPLETED
Alcohol Dependence; Cocaine Dependence
University of Pennsylvania
 2010-07 PHASE2
NCT01560507 TERMINATED
Cigarette Smoking; Nicotine Dependence
Duke University
 2012-05 PHASE2; PHASE3
NCT01370356 COMPLETED
Smoking Cessation
Pfizer
 2011-07 PHASE4
NCT01538394 COMPLETED
Smoking Cessation
Josep Maria Ramon Torrell, PhD
 2012-01 PHASE4
NCT01169610 TERMINATED
Alcoholism; Nicotine Dependence
Mayo Clinic
 2011-01 PHASE3
NCT01592695 COMPLETED
Cigarette Smoking
Iowa City Veterans Affairs Medical Center
 2012-06 PHASE2
NCT00621777 COMPLETED
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Smoking
Massachusetts General Hospital
 2008-02 PHASE4
NCT02233231 COMPLETED
Asthma
Vibeke Backer
 2011-08 PHASE4
NCT00701896 COMPLETED
Smoking; HIV Infections
Philip Diaz
 2008-10-03
NCT01444131 COMPLETED
Tobacco Dependence
University of Stellenbosch
 2011-04 PHASE2
NCT00935818 COMPLETED
Smoking
Mayo Clinic
 2009-09 PHASE2; PHASE3
NCT01303861 COMPLETED
Nicotine Dependence
Duke University
 2011-03 PHASE3
NCT01010204 COMPLETED
Smoking Cessation; Bipolar Disorder
K.N. Roy Chengappa
 2010-01 PHASE4
NCT00455650 COMPLETED
Cognition in Schizophrenia
Massachusetts General Hospital
 2007-03
NCT00931021 TERMINATED
Smoking Cessation
Yale University
 2009-07 EARLY_PHASE1
NCT01474265 COMPLETED
Smoking Cessation
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
 2011-11 PHASE4
NCT01244061 COMPLETED
Smoking Cessation
Pfizer
 2010-12 PHASE4
NCT01206010 COMPLETED
Tobacco Dependence; Smoking Cessation
Queen Mary University of London
 2011-07 PHASE3
NCT00790569 COMPLETED
Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder
Butler Hospital
 2008-09
NCT01098305 COMPLETED
Tobacco Use Disorder
University of Pennsylvania
 2011-04 PHASE2
NCT00995033 COMPLETED
Smoking Behavior; Smoking Lapse Behavior; Smoking Relapse Behavior
Maastricht University Medical Center
 2009-10 PHASE2
NCT01436474 COMPLETED
Chronic Pain; Opioid Dependence
Mayo Clinic
 2011-06 PHASE1
NCT01111149 COMPLETED
Schizophrenia; Smoking Cessation
University of Minnesota
 2009-12 PHASE2
NCT01680887 Completed
Cocaine Dependence
University of Pennsylvania
 2012-08 Phase 2
NCT01146613 COMPLETED
Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2011-02 PHASE2
NCT01078298 COMPLETED
Smoking Cessation; Depression
Pfizer
 2010-03 PHASE4
NCT00702793 WITHDRAWN
Schizophrenia; Schizoaffective; Psychosis
University of British Columbia
 2008-04 PHASE4
NCT00580398 COMPLETED
Lung Cancer
Massachusetts General Hospital
 2008-01 PHASE1; PHASE2
NCT01571167 COMPLETED
Methamphetamine Dependence; Methamphetamine Abuse; Substance Abuse
Baylor College of Medicine
 2011-01 PHASE1
NCT00934024 COMPLETED
Nicotine Dependence
Medical University of South Carolina
 2009-04
NCT01023659 COMPLETED
Tobacco Use Disorder; Smoking; Smoking Cessation
Centre for Addiction and Mental Health
 2010-04 PHASE4
NCT01141855 COMPLETED
Tobacco Use Disorder
The Queen Elizabeth Hospital
 2008-05 PHASE2; PHASE3
NCT00977249 UNKNOWN
Tobacco Dependence
University Hospital, Gentofte, Copenhagen
 2009-09 PHASE2; PHASE3
NCT00832806 COMPLETED
Additional, Effective Methods to Stop Smoking
University of British Columbia
 2008-01 PHASE1
NCT01184664 COMPLETED
Tobacco Dependence; Smoking Cessation
Queen Mary University of London
 2011-04 PHASE3
NCT01071187 UNKNOWN
Alcohol Dependence
Johannes Gutenberg University Mainz
 2010-03 PHASE2
NCT01027754 COMPLETED
Smoking Cessation; Substance-Related Disorders
Albert Einstein College of Medicine
 2009-08 PHASE4
NCT00741884 WITHDRAWN
Smoking Cessation
Pfizer
 2010-08 PHASE2
NCT01170338 UNKNOWN
Smoking; Acute Coronary Syndrome
Newark Beth Israel Medical Center
 2008-01 PHASE4
NCT01011907 COMPLETED
Substance Dependence
University of California, San Francisco
 2010-01
NCT00894166 COMPLETED
Smoking Cessation
Duke University
 2009-05 PHASE3
NCT00944554 COMPLETED
Recurrence; Smoking Cessation; Substance-Related Disorders
Johns Hopkins University
 2008-10 PHASE4
NCT00727103 COMPLETED
Schizophrenia; Schizoaffective Disorder; Alcohol Dependence; Nicotine Dependence
State University of New York - Upstate Medical University
 2008-07 PHASE4
NCT00992771 COMPLETED
Spinocerebellar Ataxia Type 3
University of South Florida
 2009-10 PHASE2
NCT00786149 COMPLETED
Tobacco Use Cessation
University of Minnesota
 2007-09 PHASE3
NCT01234142 COMPLETED
Smoking Cessation
Pfizer
 2010-11 PHASE1
NCT01093937 COMPLETED
Nicotine Dependence
Centre for Addiction and Mental Health
 2009-11
NCT00813800 COMPLETED
Smoking; Bipolar Disorder; Depression
Mark Frye
 2009-01
NCT00554840 COMPLETED
Cigarette Smoking; Schizophrenia
University of Maryland, Baltimore
 2007-11 PHASE2
NCT00744978 COMPLETED
Alzheimer's Disease
Pfizer
 2009-07 PHASE2
NCT00948155 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2009-01 PHASE4
NCT00959972 COMPLETED
Coronary Heart Disease
Ottawa Heart Institute Research Corporation
 2009-04 PHASE4
NCT00813917 COMPLETED
Nicotine Dependence
Mayo Clinic
 2009-02
NCT00749658 COMPLETED
Nicotine Dependence; Nicotine Withdrawal
University of Minnesota
 2008-11 PHASE2; PHASE3
NCT00828113 COMPLETED
Smoking
University of Wisconsin, Madison
 2009-01 PHASE4
NCT00747643 COMPLETED
Tobacco Dependence
H. Lee Moffitt Cancer Center and Research Institute
 2008-09
NCT00846859 COMPLETED
Alcohol Dependence
Sahlgrenska University Hospital
 2009-03 PHASE2
NCT00889720 COMPLETED
Smoking Cessation
Pfizer
 2009-11 PHASE4
NCT00835900 COMPLETED
Smoking Cessation
Roswell Park Cancer Institute
 2009-03 PHASE2
NCT00937508 UNKNOWN
Smoking
University Health Network, Toronto
 2008-06 PHASE4
NCT00803868 TERMINATED
Friedreich's Ataxia
University of South Florida
 2009-05 PHASE2; PHASE3
NCT01011829 COMPLETED
Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse
University of California, Los Angeles
 2009-11 PHASE2
NCT00907218 TERMINATED
Attention Deficit/Hyperactivity Disorder; Smoking Cessation
Massachusetts General Hospital
 2009-04 PHASE4
NCT00492349 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
University of Maryland, Baltimore
 2007-05 PHASE4
NCT00860028 COMPLETED
Nicotine Dependence; Smoking; Heavy Drinking
Yale University
 2008-10 PHASE2
NCT00644969 COMPLETED
Smoking Cessation
Pfizer
 2008-05 PHASE3
NCT00705523 COMPLETED
Alcoholism
University of Pennsylvania
 2008-06 PHASE2
NCT00595868 COMPLETED
Tobacco Use Disorder; Tobacco Use Cessation; Nicotine Dependence
University of Vermont Medical Center
 2008-03 PHASE2
NCT00873535 COMPLETED
Tobacco Dependence; Alcohol Dependence
Centre for Addiction and Mental Health
 2008-10
NCT00789074 COMPLETED
Tobacco Dependence; Smoking Cessation
Queen Mary University of London
 2009-07 PHASE3
NCT01013454 COMPLETED
Smoking Cessation
Pfizer
 2009-12 PHASE1
NCT00709696 COMPLETED
Nicotine Dependence
University of Minnesota
 2008-04
NCT00743847 WITHDRAWN
Schizophrenia
Pfizer
 2009-03 PHASE2
NCT00906386 UNKNOWN
Smoking
Vancouver Coastal Health
 2009-05 PHASE2
NCT00548470 COMPLETED
Schizophrenia; Tobacco Use Disorder; Nicotine Dependance
Nathan Kline Institute for Psychiatric Research
 2007-06 PHASE4
NCT00691483 COMPLETED
Smoking Cessation
Pfizer
 2008-09 PHASE4
NCT00567008 COMPLETED
Cocaine Dependence
University of Pennsylvania
 2007-12 PHASE2
NCT00713479 COMPLETED
Methamphetamine Addiction; Crystal Meth Addiction; Amphetamine Addiction
University of California, Los Angeles
 2008-07 PHASE1
NCT00749944 COMPLETED
Smoking Cessation
Pfizer
 2008-09 PHASE4
NCT00523445 COMPLETED
Schizophrenia
Inje University
 2007-09 PHASE3
NCT00594204 COMPLETED
Smoking Cessation
Pfizer
 2008-04 PHASE4
NCT00502216 COMPLETED
Smoking; Nicotine Dependence
Yale University
 2007-07 PHASE1; PHASE2
NCT00567320 COMPLETED
Cocaine Dependence; Nicotine Dependence
Yale University
 2007-03
NCT00731055 COMPLETED
Nicotine Dependence
New York State Psychiatric Institute
 2008-02 PHASE2
NCT00717093 COMPLETED
Tobacco Use Cessation
Pfizer
 2008-08 PHASE4
NCT00673595 TERMINATED
Smoking
Mayo Clinic
 2007-03
NCT00774605 COMPLETED
Smoking Cessation
Pfizer
 2008-12 PHASE1
NCT00606892 COMPLETED
Smoking Cessation
Yale University
 2007-08
NCT00525928 WITHDRAWN
Smoking; Depressive Disorder
Butler Hospital
 2007-10
NCT00731562 COMPLETED
Pharmacokinetics; Bioavailability; Smoking Cessation
Pfizer
 2008-07 PHASE1
NCT01092702 COMPLETED
Tobacco Abstinence
Mayo Clinic
 2008-04 PHASE2; PHASE3
NCT00602927 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2007-11
NCT00733967 WITHDRAWN
Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse
Baylor College of Medicine
 2008-01 PHASE1
NCT00285012 COMPLETED
Smoking Cessation
Pfizer
 2006-05 PHASE3
NCT00587769 COMPLETED
Smoking; Tobacco Use Disorder
Mayo Clinic
 2007-07 PHASE3
NCT00694044 COMPLETED
Healthy; Non-Smoking
Pfizer
 2008-04 PHASE1
NCT00301145 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
SRI International
 2005-10
NCT00661765 COMPLETED
Smoking Cessation
Pfizer
 2008-04 PHASE1
NCT00525837 COMPLETED
Depressive Disorder; Smoking
Butler Hospital
 2007-09
NCT00527150 COMPLETED
Smoking Cessation
Pfizer
 2007-10 PHASE1
NCT00282984 COMPLETED
Smoking Cessation
Pfizer
 2006-02 PHASE3
NCT00948649 COMPLETED
Nicotine Dependence
University of Pennsylvania
 2006-09 PHASE4
NCT00635401 COMPLETED
Smoking
Pfizer
 2004-05 PHASE2
NCT00150228 COMPLETED
Smoking Cessation
Pfizer
 2001-12 PHASE2
NCT00139750 COMPLETED
Smoking Cessation
Pfizer
 2004-12 PHASE2
NCT00141167 COMPLETED
Smoking Cessation
Pfizer
 2005-02 PHASE3
NCT00150254 COMPLETED
Smoking Cessation
Pfizer
 2001-09 PHASE2
NCT00143325 COMPLETED
Smoking Cessation
Pfizer
 2005-01 PHASE3
NCT00452894 COMPLETED
Smoking
Pfizer
 2007-03 PHASE1
NCT00463918 COMPLETED
Smoking Cessation
Pfizer
 2007-05 PHASE1
NCT00571805 WITHDRAWN
Nicotine Dependence
NYU Langone Health
 2007-09 PHASE1; PHASE2
NCT00141206 COMPLETED
Smoking Cessation
Pfizer
 2003-05 PHASE3
NCT00143299 COMPLETED
Smoking Cessation
Pfizer
 2003-10 PHASE3
NCT00781755 WITHDRAWN
Tobacco Use Disorder
VA Boston Healthcare System
 PHASE4
NCT00150241 COMPLETED
Smoking Cessation
Pfizer
 2000-02 PHASE2
NCT00371813 COMPLETED
Smoking Cessation
Pfizer
 2006-09 PHASE3
NCT00143364 COMPLETED
Smoking Cessation
Pfizer
 2003-06 PHASE3
NCT00143286 COMPLETED
Smoking Cessation
Pfizer
 2003-04 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the Varenicline Tartrate (CP 526555-18) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Varenicline tartrate selectively binds as a partial agonist to neuronal nicotinic acetylcholine receptors, eliciting moderate receptor activation to stimulate controlled dopamine release while competitively inhibiting nicotine binding. This dual mechanism alleviates craving and withdrawal symptoms while blunting the reward response to tobacco, providing clinical efficacy in smoking cessation and the management of nicotine dependence.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.