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ClinicalTrials.gov public records Last synced Sep 30, 2026, 9:09 AM EDT

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Showing 1–24 of 33 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Varenicline 0.5mg BID Clear all
Completed Phase 2 Interventional Results available

Varenicline for Treatment of E-cigarette Dependence

NCT05541497
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline Tartrate, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
2
States / cities
New Haven, Connecticut • Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Dec 2, 2024 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional Results available

A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

NCT01370356
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline Tartrate, Placebo
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
1,510 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
14
States / cities
Encino, California • Newport Beach, California • Jacksonville, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2014 · Synced Sep 30, 2026, 9:09 AM EDT
Withdrawn Phase 2 Interventional

Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

NCT05294263
View directory record Official record
Conditions
Tobacco Use Disorder, Cannabis Use Disorder
Interventions
Varenicline, Placebo
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Aug 27, 2024 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

NCT00664755
View directory record Official record
Conditions
Nicotine Dependence
Interventions
varenicline, transdermal nicotine patch
Drug · Device
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
140 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2013
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated May 24, 2018 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 2 Interventional

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

NCT04634071
View directory record Official record
Conditions
Smoking Cessation, Cancer, Treatment-Related
Interventions
Varenicline, Bupropion, Long-acting nicotine replacement therapy, Low-intensity counseling, High-intensity counseling, No nicotine replacement therapy, Nicotine Replacement Products
Drug · Behavioral · Other
Lead sponsor
Joseph Valentino, MD
Other
Eligibility
18 Years and older
Enrollment
126 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
3
States / cities
Bowling Green, Kentucky • Lexington, Kentucky • Owensboro, Kentucky
Source: ClinicalTrials.gov public record
Updated Feb 2, 2026 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Exercise or Relaxation for Smoking Cessation

NCT00921388
View directory record Official record
Conditions
Nicotine Dependence, Smoking Cessation
Interventions
Varenicline and smoking cessation counseling, Exercise or relaxation treatment
Other · Behavioral
Lead sponsor
UConn Health
Other
Eligibility
45 Years and older · Female only
Enrollment
301 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2017
U.S. locations
2
States / cities
Farmington, Connecticut • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 31, 2017 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Not applicable Interventional

Contingency Management and Pharmacotherapy for Smoking Cessation

NCT00683280
View directory record Official record
Conditions
Cigarette Smoking
Interventions
contingency management, Standard of Care
Behavioral · Other
Lead sponsor
UConn Health
Other
Eligibility
18 Years and older
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Farmington, Connecticut
Source: ClinicalTrials.gov public record
Updated Jan 16, 2018 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional Results available

Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

NCT00749944
View directory record Official record
Conditions
Smoking Cessation
Interventions
varenicline, placebo
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 75 Years
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
2
States / cities
Austin, Texas • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Aug 31, 2010 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional Results available

Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

NCT01010204
View directory record Official record
Conditions
Smoking Cessation, Bipolar Disorder
Interventions
Varenicline, Placebo
Drug
Lead sponsor
K.N. Roy Chengappa
Other
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
2
States / cities
DuBois, Pennsylvania • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 4, 2017 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional Results available

Varenicline Adjunctive Treatment in Schizophrenia

NCT00492349
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Interventions
Varenicline, Placebo
Drug
Lead sponsor
University of Maryland, Baltimore
Other
Eligibility
18 Years to 60 Years
Enrollment
91 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
3
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 5, 2022 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 3 Interventional Results available

Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype

NCT00894166
View directory record Official record
Conditions
Smoking Cessation
Interventions
Nicotine Patches, Nicotine patches, then bupropion & nicotine patches (Pre-Quit), Nicotine patches, then varenicline (Pre-Quit), Nicotine patches, then nicotine patches (Pre-Quit), Nicotine patches, then bupropion & nicotine patches (Post-Quit), Nicotine patches, then varenicline (Post-Quit), Nicotine patches, then nicotine patches (Post-Quit)
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years to 65 Years
Enrollment
606 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
Charlotte, Durham, Raleigh, Winston-Salem, North Carolina
Source: ClinicalTrials.gov public record
Updated Sep 23, 2013 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Smoking Cessation & Opioid Dependence Treatment Integration

NCT02854800
View directory record Official record
Conditions
Smoking Cessation, Opioid Related Disorders
Interventions
varenicline
Drug
Lead sponsor
West Virginia University
Other
Eligibility
18 Years and older
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
1
States / cities
Morgantown, West Virginia
Source: ClinicalTrials.gov public record
Updated Aug 14, 2020 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional Results available

Smoking Cessation Study In Healthy Adolescent Smokers

NCT01312909
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline 1mg BID, Varenicline 0.5mg BID, Placebo
Drug
Lead sponsor
Pfizer
Industry
Eligibility
12 Years to 19 Years
Enrollment
312 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
56
States / cities
Ozark, Alabama • Goodyear, Arizona • Little Rock, Arkansas + 46 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2018 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Combining Varenicline and Guanfacine for Smoking Cessation

NCT04198116
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline, Guanfacine ER
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
167 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2025
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Sep 30, 2026, 9:09 AM EDT
Recruiting Phase 2 Interventional

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

NCT06609369
View directory record Official record
Conditions
Tobacco Use, Tobacco Cessation, Insomnia
Interventions
Experimental health intervention, Varenicline
Behavioral · Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 65 Years
Enrollment
114 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
2
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jun 5, 2026 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

UW Quitting Using Intensive Treatment Study (QUITS)

NCT03176784
View directory record Official record
Conditions
Tobacco Dependence
Interventions
Varenicline, Nicotine patch, Placebo Patch, Placebo Pill
Drug · Other
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years and older
Enrollment
1,251 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2020
U.S. locations
2
States / cities
Madison, Wisconsin • Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jan 23, 2023 · Synced Sep 30, 2026, 9:09 AM EDT
Terminated Phase 2 Interventional Accepts healthy volunteers Results available

Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

NCT03722966
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline, Oral Nicotine Replacement Therapy (NRT), Medication Reminders, Tobacco Cessation Counseling
Drug · Behavioral
Lead sponsor
University of Oklahoma
Other
Eligibility
18 Years to 65 Years
Enrollment
34 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2022
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Feb 6, 2024 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 1 Interventional

Pilot Study of Varenicline to Treat Opioid Dependence

NCT01436474
View directory record Official record
Conditions
Chronic Pain, Opioid Dependence
Interventions
Varenicline, Placebo
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
21 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Jan 23, 2013 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 4 Interventional

Smoking Study With Behavioral Therapy for Hypertensive Patients

NCT00879177
View directory record Official record
Conditions
Cigarette Smoking, Hypertension
Interventions
Varenicline, behavioral therapy
Drug · Behavioral
Lead sponsor
UConn Health
Other
Eligibility
18 Years and older
Enrollment
203 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2014
U.S. locations
1
States / cities
Farmington, Connecticut
Source: ClinicalTrials.gov public record
Updated Apr 10, 2017 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 3 Interventional Results available

Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).

NCT00285012
View directory record Official record
Conditions
Smoking Cessation
Interventions
placebo, Varenicline Tartarate
Drug
Lead sponsor
Pfizer
Industry
Eligibility
35 Years and older
Enrollment
504 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
22
States / cities
Birmingham, Alabama • Los Angeles, California • Denver, Colorado + 15 more
Source: ClinicalTrials.gov public record
Updated Apr 20, 2010 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 3 Interventional Results available

Varenicline for Nicotine Dependence Among Those With HIV/AIDS

NCT01710137
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Varenicline, Placebo, Smoking Cessation Counseling
Drug · Behavioral
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
179 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2018
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 18, 2019 · Synced Sep 30, 2026, 9:09 AM EDT
Recruiting Phase 4 Interventional

Varenicline for Smoking Reduction in Veterans Not Ready To Quit

NCT06966362
View directory record Official record
Conditions
Veterans, Tobacco Use Disorder, Cigarette Smoking, Tobacco Dependence
Interventions
Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge, Cessation-Phase Combination Nicotine Replacement Therapy (NRT), Cessation-Phase Varenicline, Motivation-Phase Counseling, Cessation-Phase Counseling
Drug · Behavioral
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
21 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
4
States / cities
San Diego, California • Minneapolis, Minnesota • Durham, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 30, 2026, 9:09 AM EDT
Completed Phase 2 Interventional Results available

The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

NCT00580853
View directory record Official record
Conditions
Smoking Lapse Behavior
Interventions
varenicline, bupropion, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
21 Years to 55 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2016
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Feb 8, 2018 · Synced Sep 30, 2026, 9:09 AM EDT
Terminated No phase listed Observational

Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

NCT01532232
View directory record Official record
Conditions
Breast Cancer, Tobacco Dependence
Interventions
placebo, varenicline
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Dec 23, 2015 · Synced Sep 30, 2026, 9:09 AM EDT