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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:49 PM EDT

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Showing 1–24 of 278 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Varenicline Clear all
Completed Phase 4 Interventional Accepts healthy volunteers

OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers

NCT05161208
View directory record Official record
Conditions
Dry Eye
Interventions
OC-01 (varenicline 0.6mg/ml) Nasal Spray, Placebo (vehicle) nasal spray
Drug
Lead sponsor
Center for Ophthalmic and Vision Research, LLC
Other
Eligibility
18 Years to 70 Years
Enrollment
75 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Nov 3, 2022 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Human Laboratory Study of Varenicline for Alcohol Use Disorder

NCT03035708
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Varenicline, Placebo oral capsule
Drug
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Eligibility
21 Years and older
Enrollment
47 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
2
States / cities
New Haven, Connecticut • Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Oct 23, 2019 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin

NCT00774605
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline free base solution, Varenicline free base patch
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jan 26, 2009 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 3 Interventional

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

NCT00143286
View directory record Official record
Conditions
Smoking Cessation
Interventions
varenicline (CP-526,555)
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 75 Years
Enrollment
2,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
6
States / cities
Santa Ana, California • West Palm Beach, Florida • Lexington, Kentucky + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 4, 2007 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Varenicline for the Treatment of Smokeless Tobacco

NCT00813917
View directory record Official record
Conditions
Nicotine Dependence
Interventions
varenicline, placebo
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
76 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2011
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 16, 2012 · Synced Oct 19, 2026, 1:49 PM EDT
Recruiting Phase 4 Interventional

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

NCT04604509
View directory record Official record
Conditions
Cigarette Smoking-Related Carcinoma
Interventions
Bupropion Hydrochloride Controlled-release, Nicotine Replacement, Questionnaire Administration, Tobacco Cessation Counseling, Varenicline
Drug · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
2,010 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2028
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 7, 2026 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Effects of Varenicline on Cigarette Self Administration

NCT00731055
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Varenicline, Placebo
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
21 Years to 45 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2009
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 18, 2018 · Synced Oct 19, 2026, 1:49 PM EDT
Terminated No phase listed Observational Accepts healthy volunteers

Alternate Nicotine Delivery Systems and Airway Epithelial Biology

NCT01974063
View directory record Official record
Conditions
Smoking, Smoking Cessation
Interventions
Not listed
Lead sponsor
Weill Medical College of Cornell University
Other
Eligibility
18 Years and older
Enrollment
96 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2017
U.S. locations
2
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 3, 2018 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 2 Interventional Results available

Chantix for Treating Cocaine Dependence

NCT00567008
View directory record Official record
Conditions
Cocaine Dependence
Interventions
varenicline, placebo
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 65 Years
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 7, 2013 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Long-term Varenicline Treatment for Smoking Cessation

NCT00828113
View directory record Official record
Conditions
Smoking
Interventions
varenicline, Individual smoking cessation counseling
Drug · Behavioral
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 75 Years
Enrollment
101 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2011
U.S. locations
2
States / cities
Madison, Wisconsin • Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Nov 20, 2015 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 1 Interventional Results available

An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers

NCT00713479
View directory record Official record
Conditions
Methamphetamine Addiction, Crystal Meth Addiction, Amphetamine Addiction
Interventions
Varenicline, then placebo, Placebo, then varenicline
Drug
Lead sponsor
University of California, Los Angeles
Other
Eligibility
18 Years to 55 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 13, 2018 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Smoking Cessation Intervention for Thoracic Patients

NCT00580398
View directory record Official record
Conditions
Lung Cancer
Interventions
Smoking cessation counseling, varenicline
Behavioral · Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
Not listed
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 12, 2018 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Tobacco Cessation at FDNY

NCT05997225
View directory record Official record
Conditions
Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
Interventions
opt out enrollment, tailored counseling, varenicline started prior to target quit date, opt in enrollment, non-tailored counseling, varenicline started prior to target quit date
Other
Lead sponsor
Albert Einstein College of Medicine
Other
Eligibility
40 Years and older
Enrollment
23 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Brooklyn, New York
Source: ClinicalTrials.gov public record
Updated Jan 29, 2026 · Synced Oct 19, 2026, 1:49 PM 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 Oct 19, 2026, 1:49 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Measuring Smoking Behaviors While Using Varenicline

NCT00948155
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Varenicline
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
21 Years to 65 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2010
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 16, 2014 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Early Phase 1 Interventional Results available

Hollings Cancer Center Varenicline Sampling Study

NCT03742154
View directory record Official record
Conditions
Smoking, Smoking Cessation, Smoking, Tobacco, Smoking, Cigarette
Interventions
Varenicline 0.5 MG
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
99 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Oct 28, 2020 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 4 Interventional Results available

Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors

NCT00802919
View directory record Official record
Conditions
Schizophrenia, Cigarette Smoking
Interventions
Varenicline, Placebo for varenicline
Drug
Lead sponsor
Nathan Kline Institute for Psychiatric Research
Other
Eligibility
18 Years to 65 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2013
U.S. locations
2
States / cities
New York, New York • Orangeburg, New York
Source: ClinicalTrials.gov public record
Updated Dec 2, 2017 · Synced Oct 19, 2026, 1:49 PM EDT
Withdrawn Phase 2 Interventional

Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis

NCT07171112
View directory record Official record
Conditions
Pancreatitis, Chronic, Pancreatitis, Acute, Recurrent Acute Pancreatitis, Smoking (Tobacco) Addiction
Interventions
Standard Varenicline Dosing (1 mg BID), Bupropion 150 mg twice daily, Increased Varenicline Dosing (1mg TID)
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Oct 19, 2026, 1:49 PM EDT
Not listed Phase 4 Interventional

Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome

NCT01170338
View directory record Official record
Conditions
Smoking, Acute Coronary Syndrome
Interventions
Varenicline 100 mg by mouth twice daily, control
Drug
Lead sponsor
Newark Beth Israel Medical Center
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2008
U.S. locations
1
States / cities
Newark, New Jersey
Source: ClinicalTrials.gov public record
Updated Jul 27, 2010 · Synced Oct 19, 2026, 1:49 PM EDT
Recruiting Phase 2 Interventional

Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease

NCT06679374
View directory record Official record
Conditions
Parkinson Disease
Interventions
Placebo, Varenicline
Drug
Lead sponsor
Vikas Kotagal
Other
Eligibility
45 Years and older
Enrollment
102 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Mar 31, 2026 · Synced Oct 19, 2026, 1:49 PM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

NCT05642715
View directory record Official record
Conditions
Hiv, Tobacco Use
Interventions
EX+, Varenicline, HR, TAU
Behavioral · Drug
Lead sponsor
Montefiore Medical Center
Other
Eligibility
40 Years to 79 Years
Enrollment
400 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2027
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Oct 19, 2026, 1:49 PM EDT
Recruiting Phase 4 Interventional Accepts healthy volunteers

E-cigarette Cessation in Adults Who Co-use Cannabis

NCT06688539
View directory record Official record
Conditions
Nicotine Dependence, Tobacco Use Disorder
Interventions
Varenicline Pill, Contingency management, Counseling
Drug · Behavioral
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years to 40 Years
Enrollment
105 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2027
U.S. locations
3
States / cities
Charleston, South Carolina • Lancaster, South Carolina • Pickens, South Carolina
Source: ClinicalTrials.gov public record
Updated Jun 12, 2026 · Synced Oct 19, 2026, 1:49 PM EDT
Active, not recruiting Phase 2 Interventional

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

NCT06006143
View directory record Official record
Conditions
Alcohol Use Disorder, Hiv, Tobacco Use Disorder
Interventions
Varenicline
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Decatur, Georgia
Source: ClinicalTrials.gov public record
Updated Apr 16, 2026 · Synced Oct 19, 2026, 1:49 PM EDT
Completed Phase 1Phase 2 Interventional Results available

STARS (Smoking Treatment And Remote Sampling) Study

NCT04525755
View directory record Official record
Conditions
Smoking, Smoking Cessation, Tobacco Smoking, Cigarette Smoking
Interventions
Varenicline 0.5 MG, Nicotine Replacement Therapy (NRT)
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
652 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Feb 17, 2026 · Synced Oct 19, 2026, 1:49 PM EDT