Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

ClinicalTrials.gov 57 recruiting now official registry

Smoking Cessation clinical trials

Every US clinical trial registered for Smoking Cessation — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

189 US clinical trials · 57 currently recruiting

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 Francis

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING NA 5,000 participants

CONNECT Cancer Survivors With Tobacco Treatment

Washington University School of Medicine

NCT07020273

RECRUITING NA 3,200 participants

Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network

Children's Hospital of Philadelphia

NCT06582693

RECRUITING NA 2,376 participants

Veteran Social Support for Enhancing Use of Smoking Cessation Treatment

VA Office of Research and Development

NCT05868421

RECRUITING 2,000 participants

Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies

Weill Medical College of Cornell University

NCT01776398

RECRUITING NA 1,600 participants

Testing the mHealth App Intervention for Nondaily Smokers "SiS4"

Massachusetts General Hospital

NCT06678243

RECRUITING NA 1,500 participants

Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors

Northwestern University

NCT05687604

RECRUITING NA 1,312 participants

Family-Based Financial Incentives Intervention for Smoking Cessation

Mayo Clinic

NCT06556433

RECRUITING Phase 3 1,188 participants

Tobacco Education and Lung Health Study (TEAL)

Georgetown University

NCT06290869

RECRUITING NA 1,000 participants

Bladder Cancer Screening Trial

University of Texas Southwestern Medical Center

NCT05646485

RECRUITING NA 850 participants

Personalized Tobacco Treatment in Primary Care (MOTIVATE)

Washington University School of Medicine

NCT05846841

RECRUITING NA 840 participants

Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women

Duke University

NCT04985903

RECRUITING NA 800 participants

Take A Break - Rural

Wake Forest University Health Sciences

NCT05790486

RECRUITING Phase 1 780 participants

Overcoming Nicotine Dependence to Enable Quitting

Rush University Medical Center

NCT05513872

RECRUITING NA 768 participants

Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia

University of Virginia

NCT05660525

RECRUITING NA 760 participants

Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities

University of California, San Francis

NCT07049757

RECRUITING NA 672 participants

Enhancing Smoking Cessation Via Telehealth Options in Primary Care

Medical University of South Carolina

NCT05493254

RECRUITING Phase 4 608 participants

Smoking Cessation Program in the Construction Sector

University of Miami

NCT06098144

RECRUITING NA 576 participants

Urban and Reservation Implementation of All Nations Breath of Life

Lehigh University

NCT04931810

RECRUITING Phase 3 500 participants

Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment

University of Kansas Medical Center

NCT05732272

RECRUITING Phase 4 500 participants

The Avenues Study: Dual Use Cessation

University of Wisconsin, Madison

NCT06474299

RECRUITING Phase 4 500 participants

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

New York University

NCT06598397

RECRUITING NA 440 participants

Technology Assisted Motivational Interviewing

University of California, San Francis

NCT06713603

RECRUITING Phase 2 424 participants

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Baystate Medical Center

NCT05733767

RECRUITING NA 416 participants

American Indian Smokefree Native RCT

Masonic Cancer Center, University of Minnesota

NCT06544811

RECRUITING NA 408 participants

Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

University of Rochester

NCT06926608

RECRUITING Phase 3 400 participants

V+PSF-M for Tobacco Cessation in HIV Care in India

University of Colorado, Denver

NCT05786547

RECRUITING NA 314 participants

Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Wake Forest University Health Sciences

NCT06883097

RECRUITING Phase 4 300 participants

The Options 2 Study

University of Wisconsin, Madison

NCT06595459

RECRUITING NA 288 participants

Investigating Novel Smoking Cessation Primary Care Interventions in Rural Environments

Medical University of South Carolina

NCT05764759

RECRUITING Phase 4 279 participants

Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

University of Minnesota

NCT04783857

RECRUITING NA 250 participants

Intervening to Promote Tobacco Cessation Following Psychiatric Hospitalization

University of Texas at Austin

NCT05672914

RECRUITING NA 200 participants

Wellness Intervention for Smoking and HIV

University of Arizona

NCT04725617

RECRUITING NA 147 participants

CONNECTing to LungCare

University of California, San Francis

NCT06213532

RECRUITING NA 112 participants

Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients

Washington University School of Medicine

NCT07166120

RECRUITING NA 94 participants

New Strategies to Enhance Smoking Cessation

University of Chicago

NCT06751927

RECRUITING NA 90 participants

Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients

H. Lee Moffitt Cancer Center and Research Institute

NCT06909357

RECRUITING NA 82 participants

Re-Connect Application for Smoking Cessation

Rowan University

NCT05224154

RECRUITING NA 75 participants

Quit-Smoking Study for Native Hawaiians

University of Hawaii

NCT07075575

RECRUITING Phase 2 64 participants

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

University of California, Los Angeles

NCT06617312

RECRUITING NA 60 participants

Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

Brown University

NCT06948058

RECRUITING NA 50 participants

ACT Lung Health Intervention: Phase Two

Dana-Farber Cancer Institute

NCT06945120

RECRUITING NA 50 participants

Remote Smoking Cessation in Hospitalized Cardiac Patients

University of Vermont Medical Center

NCT05738408

RECRUITING NA 50 participants

Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)

Southcentral Foundation

NCT06556238

RECRUITING NA 50 participants

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Medical University of South Carolina

NCT06678789

RECRUITING NA 50 participants

Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

The University of Texas Health Science Center, Houston

NCT05276050

RECRUITING NA 50 participants

Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors

Rutgers, The State University of New Jersey

NCT07210567

RECRUITING NA 48 participants

Healing Within: Mindfulness Smoking Cessation Intervention

National Heart, Lung, and Blood Institute (NHLBI)

NCT07013968

RECRUITING NA 48 participants

Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

Black Hills Center for American Indian Health

NCT06357767

RECRUITING NA 46 participants

Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study

Wake Forest University Health Sciences

NCT05460676

RECRUITING Phase 1 40 participants

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

Yale University

NCT06027840

RECRUITING NA 38 participants

Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Stony Brook University

NCT05724810

RECRUITING NA 30 participants

Preliminary Effectiveness of Enhanced Text Message + Incentives

University of Kansas Medical Center

NCT07420621

RECRUITING NA 30 participants

A Culturally Tailored Smartphone Application for African American Smokers

University of Oklahoma

NCT05188287

RECRUITING NA 20 participants

Trauma-Informed Care for Smoking Cessation for Pregnancy

University of California, San Francis

NCT07129590

RECRUITING NA 20 participants

Contingency Management to Promote Smoking Cessation

University of Kansas Medical Center

NCT06456242

RECRUITING Phase 1 20 participants

Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Yale University

NCT07224087

RECRUITING NA 10 participants

A Study Evaluating the Use of an Indoor Air Quality Monitor to Promote a Smoke-free Home

Memorial Sloan Kettering Cancer Center

NCT06693700

ACTIVE NOT RECRUITING NA 1,122 participants

Evaluation of an "Opt-Out" Inpatient Smoking Cessation Service on Smoking Behavior Study #1

Medical University of South Carolina

NCT04827914

ACTIVE NOT RECRUITING 1,072 participants

A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

Memorial Sloan Kettering Cancer Center

NCT00591175

ACTIVE NOT RECRUITING Phase 4 807 participants

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Memorial Sloan Kettering Cancer Center

NCT03315910

ACTIVE NOT RECRUITING NA 700 participants

A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities

University of Minnesota

NCT05671380

ACTIVE NOT RECRUITING NA 638 participants

Automated Video-Assisted Smoking Treatment for People Living With HIV

H. Lee Moffitt Cancer Center and Research Institute

NCT05014282

ACTIVE NOT RECRUITING Early Phase 1 630 participants

Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

M.D. Anderson Cancer Center

NCT03059940

ACTIVE NOT RECRUITING NA 532 participants

Mobile Contingency Management for Smoking Cessation

University of Oklahoma

NCT04881630

ACTIVE NOT RECRUITING NA 520 participants

Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

H. Lee Moffitt Cancer Center and Research Institute

NCT05004662

ACTIVE NOT RECRUITING NA 500 participants

Telephone All Nations Breath of Life

Lehigh University

NCT04764175

ACTIVE NOT RECRUITING NA 440 participants

VR Smoking Cessation During a Dental Hygiene Visit

Boston University

NCT04524533

ACTIVE NOT RECRUITING NA 360 participants

Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)

H. Lee Moffitt Cancer Center and Research Institute

NCT05645146

ACTIVE NOT RECRUITING NA 300 participants

Construal Level as a Novel Pathway for Affect Regulation and Cancer Control

University of Oregon

NCT04620915

ACTIVE NOT RECRUITING NA 263 participants

Implementation of a System-level Tobacco Treatment Intervention

Dana-Farber Cancer Institute

NCT02816697

ACTIVE NOT RECRUITING NA 226 participants

Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV

Seattle Institute for Biomedical and Clinical Research

NCT04505371

ACTIVE NOT RECRUITING NA 153 participants

Digitally Enhanced Smoking Cessation for High Risk Smokers

Dana-Farber Cancer Institute

NCT04691297

ACTIVE NOT RECRUITING Early Phase 1 51 participants

Smoking Cessation Treatment for Head & Neck Cancer Patients

M.D. Anderson Cancer Center

NCT01098955

ACTIVE NOT RECRUITING NA 44 participants

Forward to Quit: A Person-centered Mobile Technology Intervention for Smoking Cessation Among Transgender Adults

University of Colorado, Denver

NCT07181551

ACTIVE NOT RECRUITING NA 8 participants

Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study

M.D. Anderson Cancer Center

NCT05038852

COMPLETED NA 6,006 participants

Randomized Clinical Trial to Reduce Harm From Tobacco

University of Pennsylvania

NCT02328794

COMPLETED 3,070 participants

Young Adult Smoker's Treatment Demand

University of Illinois at Chicago

NCT01569529

COMPLETED NA 2,826 participants

Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke

University of Rochester

NCT05722132

COMPLETED Phase 3 2,000 participants

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

Pfizer

NCT00143286

COMPLETED NA 1,944 participants

Helping Poor Smokers Quit

Washington University School of Medicine

NCT03194958

COMPLETED NA 1,900 participants

Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET

US Department of Veterans Affairs

NCT00057070

COMPLETED Phase 4 1,528 participants

Dissemination of Tobacco Tactics for Hospitalized Smokers

University of Michigan

NCT01309217

COMPLETED NA 1,417 participants

Spanish-Language Smoking Cessation Trial

H. Lee Moffitt Cancer Center and Research Institute

NCT02945787

COMPLETED NA 1,298 participants

Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)

University of Tennessee

NCT00632411

COMPLETED NA 1,280 participants

Expert System and Family Assisted Interventions for Chinese Smokers

University of California, San Francis

NCT00714467

COMPLETED NA 1,236 participants

A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Medical University of South Carolina

NCT01509586

COMPLETED Phase 4 1,086 participants

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

University of Wisconsin, Madison

NCT01553084

COMPLETED Phase 4 987 participants

Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

University of Wisconsin, Madison

NCT01087905

COMPLETED Phase 2 980 participants

Twitter-enabled Mobile Messaging for Smoking Relapse Prevention (Tweet2Quit)

University of California, Irvine

NCT02823028

COMPLETED NA 961 participants

Computer-Facilitated 5A's for Smoking Cessation in Primary Care

University of California, San Francis

NCT02046408

COMPLETED Phase 4 822 participants

Genetically Informed Smoking Cessation Trial

Washington University School of Medicine

NCT02351167

COMPLETED Phase 3 750 participants

Disease Management for Smoking Cessation

University of Kansas Medical Center

NCT00440115

COMPLETED Phase 3 730 participants

An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

Pfizer

NCT00143325

COMPLETED Phase 3 714 participants

Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

Pfizer

NCT00282984

COMPLETED Phase 4 659 participants

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

Pfizer

NCT00691483

COMPLETED Phase 2 646 participants

Pharmacogenetics, Emotional Reactivity and Smoking

M.D. Anderson Cancer Center

NCT00507728

COMPLETED Phase 3 641 participants

Combining Varenicline and Bupropion for Smoking Cessation

M.D. Anderson Cancer Center

NCT00943618

COMPLETED NA 633 participants

Connect to Quit for Smoking

University of Pittsburgh

NCT01299896

COMPLETED Phase 3 606 participants

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

Duke University

NCT00894166

COMPLETED Phase 4 517 participants

Identifying Treatments to Motivate Smokers to Quit

University of Wisconsin, Madison

NCT01122238

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

ClinicalTrials.gov lists 189 US studies indexed under Smoking Cessation, and 57 of those are currently open to recruitment — roughly 30% of the total volume on the registry. 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.

The phase distribution for Smoking Cessation shows 33 late-stage studies (Phase 3 and Phase 4 combined) alongside 30 earlier-phase entries (Phase 1 through Phase 2). 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.

Top sponsor activity for Smoking Cessation is led by University of California, San Francis with 10 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 100 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. 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.

Related

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 →