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ClinicalTrials.gov public records Last synced Sep 30, 2026, 2:35 AM EDT

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Showing 25–48 of 277 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: varenicline Clear all
Completed Phase 3 Interventional Results available

Varenicline for Adolescent Smoking Cessation

NCT01509547
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Varenicline, placebo
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
14 Years to 21 Years
Enrollment
157 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2018
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Jul 1, 2020 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 1 Interventional

Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use

NCT06027840
View directory record Official record
Conditions
Cigarette Smoking, E-Cigarette Use, Smoking Cessation
Interventions
Varenicline, Counseling, Guided Self-Change Booklets
Drug · Behavioral
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jun 8, 2026 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study

NCT00596882
View directory record Official record
Conditions
Smoking Cessation
Interventions
Message Prime
Other
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 65 Years
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2009
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 2, 2009 · Synced Sep 30, 2026, 2:35 AM EDT
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 Sep 30, 2026, 2:35 AM EDT
Completed Not applicable Interventional Results available

Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

NCT00790569
View directory record Official record
Conditions
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
Interventions
nicotine, varenicline, placebo
Drug · Other
Lead sponsor
Butler Hospital
Other
Eligibility
18 Years to 120 Years
Enrollment
315 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2012
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Jun 6, 2018 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 2 Interventional Results available

Effects of Varenicline on Smoking Reminders

NCT01524627
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Varenicline, Placebo
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 60 Years
Enrollment
124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Aug 17, 2017 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Randomized Clinical Trial to Reduce Harm From Tobacco

NCT02328794
View directory record Official record
Conditions
Smoking Cessation
Interventions
E-cigarette free access, E-cigarette/NRT/Zyban/Chantix Choice, Outcome Incentive arm, Loss framing incentive arm, Control
Behavioral
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 99 Years
Enrollment
6,006 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 2, 2017 · Synced Sep 30, 2026, 2:35 AM EDT
Recruiting Phase 4 Interventional

The Avenues Study: Dual Use Cessation

NCT06474299
View directory record Official record
Conditions
Smoking Cessation, Electronic Cigarette Use
Interventions
Varenicline, Nicotine patch, Dual Focused Cessation Counseling, Smoking Focused Cessation Counseling, Counseling Intensity: 1 Session, Counseling Intensity: 4 Sessions
Drug · Behavioral · Other
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
21 Years and older
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 13, 2026 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Not applicable Interventional Results available

Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

NCT01691105
View directory record Official record
Conditions
Tobacco Use Cessation, Smoking Cessation, Smoking, Tobacco Use Disorder
Interventions
AD + Integrated Tobacco Order Set
Other
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
1,044 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Sep 5, 2021 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 4 Interventional Results available

Smoking Cessation Treatment for Methadone Maintenance Patients

NCT01027754
View directory record Official record
Conditions
Smoking Cessation, Substance-Related Disorders
Interventions
Varenicline, Placebo
Drug
Lead sponsor
Albert Einstein College of Medicine
Other
Eligibility
18 Years and older
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated May 26, 2021 · Synced Sep 30, 2026, 2:35 AM 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 Sep 30, 2026, 2:35 AM EDT
Not listed Phase 3 Interventional Accepts healthy volunteers

Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Photorefractive Keratectomy (PRK)

NCT05045508
View directory record Official record
Conditions
Dry Eye
Interventions
OC-01 (varenicline 0.6mg/ml) nasal spray, Placebo (vehicle) Nasal Spray
Drug
Lead sponsor
Brandon Baartman
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Sep 22, 2021 · Synced Sep 30, 2026, 2:35 AM 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 Sep 30, 2026, 2:35 AM EDT
Completed Not applicable Interventional Results available

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

NCT01771627
View directory record Official record
Conditions
Tobacco Use Disorder
Interventions
varenicline, nicotine patch
Drug
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Sep 28, 2020 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 4 Interventional Results available

Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

NCT00691483
View directory record Official record
Conditions
Smoking Cessation
Interventions
placebo, varenicline
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 75 Years
Enrollment
659 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
12
States / cities
Litchfield Park, Arizona • Los Angeles, California • Santa Ana, California + 9 more
Source: ClinicalTrials.gov public record
Updated Nov 20, 2015 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 2 Interventional Results available

Varenicline Treatment of Alcohol Dependence in Smokers

NCT01553136
View directory record Official record
Conditions
Alcoholism, Alcohol Abuse, Smoking, Alcohol Drinking
Interventions
Varenicline
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 70 Years
Enrollment
131 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
2
States / cities
New Haven, Connecticut • New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 6, 2020 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Not applicable Interventional Results available

Improving Adherence to Smoking Cessation Medication Among PLWHA

NCT01898195
View directory record Official record
Conditions
Tobacco Use Cessation
Interventions
Varenicline, Text Message, Adherence Behavioral Therapy
Drug · Behavioral
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
158 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 18, 2017 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Not applicable Interventional Results available

Financial Incentives for Homeless Smokers: A Community-based RCT

NCT04445662
View directory record Official record
Conditions
Tobacco Smoking
Interventions
Financial incentives, Varenicline, Tobacco coaching
Behavioral · Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Enrollment
184 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 21, 2025 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Early Phase 1 Interventional

Varenicline + Prazosin for Heavy Drinking Smokers

NCT02193256
View directory record Official record
Conditions
Cigarette Smoking, Alcohol Use Disorders
Interventions
Varenicline, Prazosin, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Mar 12, 2020 · Synced Sep 30, 2026, 2:35 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, 2:35 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, 2:35 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Maintaining Nonsmoking

NCT01162239
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Varenicline, Initial Individual counseling, Check-ins with medical staff, Extended Individual Counseling - Health Model, Extended Individual Counseling - Relapse Prevention Model
Drug · Behavioral
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
216 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2016
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Nov 12, 2020 · Synced Sep 30, 2026, 2:35 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.

NCT06029907
View directory record Official record
Conditions
Smoking Cessation, Pain
Interventions
Smoking cessation and pain management intervention, Varenicline
Other · Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 30, 2026, 2:35 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, 2:35 AM EDT