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ClinicalTrials.gov 57 recruiting now official registry

Smoking Cessation clinical trials

57 of 189 indexed Smoking Cessation trials are currently recruiting.

189 US clinical trials · 57 currently recruiting

Smoking Cessation is the subject of 189 registered US clinical trials on ClinicalTrials.gov, 57 of them currently open to new participants. 33 are in Phase 3-4 (later-stage) and 30 in Phase 1-2 (earlier-stage). The most active sponsor is University of California, San Francisco, running 10 of these trials.

The research picture

Smoking Cessation has 189 registered US clinical trials, 57 of them open to new participants right now, about 30% of the total.

57
recruiting participants now
30%
of trials open to enrollment
33
in Phase 3–4 (later-stage)
10
top sponsor: University of California, San Francisco
Phase 115Phase 215Phase 314Phase 419

Active & Recent Trials

189 total, page 3 of 4

COMPLETED Phase 3 504 participants

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

Pfizer

NCT00285012

COMPLETED Phase 3 500 participants

Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Nabi Biopharmaceuticals

NCT01178346

COMPLETED Phase 4 498 participants

A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Pfizer

NCT01244061

COMPLETED NA 496 participants

Quit Smoking Program for Lung Cancer Patients' Families (The Family Ties Project)

Duke University

NCT00345891

COMPLETED NA 442 participants

Promoting Smoking Cessation in Carpenters

Washington University School of Medicine

NCT01878214

COMPLETED Phase 4 410 participants

Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants

NYU Langone Health

NCT03187730

COMPLETED NA 408 participants

Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers

University of Rochester

NCT05278481

COMPLETED NA 400 participants

Increasing Physical Activity as Part of a Smoking Cessation Program

National Heart, Lung, and Blood Institute (NHLBI)

NCT00403312

COMPLETED Phase 3 392 participants

Individualizing Pharmacotherapy for African American Smokers

University of Kansas Medical Center

NCT03897439

COMPLETED NA 387 participants

Cigarette Pack Inserts for Smoking Cessation

University of South Carolina

NCT04075682

COMPLETED NA 352 participants

Patient Navigation and Financial Incentives to Promote Smoking Cessation

Boston Medical Center

NCT02351609

COMPLETED Phase 2 333 participants

Efficacy of Naltrexone in Women's Smoking Cessation

University of Chicago

NCT00271024

COMPLETED Phase 3 320 participants

Nicotine Mouth Film for Craving Relief.

GlaxoSmithKline

NCT01702532

COMPLETED Phase 4 313 participants

Varenicline OTC Trial on Efficacy and Safety

Arizona State University

NCT03557294

COMPLETED NA 305 participants

Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

University of Tennessee

NCT03156660

COMPLETED NA 303 participants

Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial

Massachusetts General Hospital

NCT01871506

COMPLETED 300 participants

A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation

Nabi Biopharmaceuticals

NCT01304810

COMPLETED NA 298 participants

Smoking Reduction and Cessation Interventions for Chinese

University of California, San Francisco

NCT00714532

COMPLETED NA 288 participants

Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain

Abramson Cancer Center at Penn Medicine

NCT02906787

COMPLETED Phase 4 278 participants

Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

University of Kansas Medical Center

NCT02244918

COMPLETED NA 276 participants

Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)

Yale University

NCT02658032

COMPLETED 274 participants

Cognition and Smoking Relapse (HCS)

University of Pennsylvania

NCT03169101

COMPLETED NA 224 participants

Pager-Assisted Smoking Cessation Treatment

University of California, San Francisco

NCT01207310

COMPLETED NA 212 participants

P60 Program Project Grant-Outreach for Smoke-Free Homes

University of Minnesota

NCT01574560

COMPLETED NA 165 participants

A Facebook Intervention for Young Sexual and Gender Minority Smokers

University of California, San Francisco

NCT03259360

COMPLETED NA 164 participants

Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA

Center for Innovative Public Health Research

NCT01516632

COMPLETED NA 164 participants

Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

North Shore Medical Center

NCT01791803

COMPLETED Phase 2 163 participants

Facilitating Smoking Cessation With Reduced Nicotine Cigarettes

H. Lee Moffitt Cancer Center and Research Institute

NCT02796391

COMPLETED NA 159 participants

Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers

American University

NCT04383782

COMPLETED NA 158 participants

Innovative Digital Therapeutic for Smoking Cessation

My Digital Study

NCT03694327

COMPLETED NA 150 participants

WeChat Quit Coach Pilot Study

NYU Langone Health

NCT05130788

COMPLETED NA 139 participants

Smoking Cessation in NYC

Temple University

NCT04489524

COMPLETED NA 130 participants

Phone-Based Postpartum Continuing Care for Smoking Cessation

Battelle Memorial Institute

NCT01684592

COMPLETED Phase 2 126 participants

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Joseph Valentino, MD

NCT04634071

COMPLETED NA 125 participants

Auriculotherapy for Smoking Cessation: Pilot

US Department of Veterans Affairs

NCT01189110

COMPLETED NA 122 participants

Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults

University of Minnesota

NCT01497158

COMPLETED NA 121 participants

A Guided Imagery Tobacco Cessation Intervention Delivered by a Quit Line and Website

University of Arizona

NCT02968381

COMPLETED Phase 2 121 participants

Guanfacine Clinical Trial for Smoking Cessation

Yale University

NCT02051309

COMPLETED NA 120 participants

Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation

University of Colorado, Denver

NCT04897568

COMPLETED Phase 2 120 participants

Provoked Craving Relief Study by NRT

GlaxoSmithKline

NCT01476202

COMPLETED 119 participants

Physiological, Cognitive and Cerebral Activity Changes as a Function of Cigarette Smoking (With or Without Nicotine) and Tobacco Abstinence

National Institute on Drug Abuse (NIDA)

NCT01034384

COMPLETED NA 119 participants

Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation

Brown University

NCT03068611

COMPLETED Phase 4 104 participants

Relapse Prevention With Varenicline

Johns Hopkins University

NCT00944554

COMPLETED NA 100 participants

Computer MI for Tobacco Quitline Engagement in Smokers Living With HIV

Butler Hospital

NCT01886924

COMPLETED Early Phase 1 99 participants

Hollings Cancer Center Varenicline Sampling Study

Medical University of South Carolina

NCT03742154

COMPLETED NA 92 participants

Neuroimaging Studies of Smoking and Treatment

University of Kansas Medical Center

NCT03085602

COMPLETED Phase 3 87 participants

Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation

Lindner Center of HOPE

NCT00280839

COMPLETED NA 83 participants

Contingency Management for Smoking Cessation

University of California, San Francisco

NCT04982952

COMPLETED NA 80 participants

Mechanisms of Mindfulness for Smoking Cessation

Brown University

NCT02943499

COMPLETED NA 80 participants

Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

Virginia Commonwealth University

NCT00390559

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Phase Distribution

PhaseTrial count
Phase 1 15
Phase 2 15
Phase 3 14
Phase 4 19

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Smoking Cessation Trial Landscape

189 indexed Smoking Cessation studies · 57 recruiting (30%).

Phase mix: 33 late (III/IV) vs 30 early (I/II).

Top sponsor: University of California, San Francisco (10 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Smoking Cessation?

PlainTrial tracks 189 US clinical trials for Smoking Cessation, of which 57 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Smoking Cessation?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.