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

2026 data Public-data reference. official source

Tobacco Use Disorder

Open-data reference.

75 US clinical trials · 19 currently recruiting

Active & Recent Trials

RECRUITING NA 350 participants

Young Adult Tobacco/Nicotine and Cannabis Co-use

Medical University of South Carolina

NCT06239350

RECRUITING Phase 2 308 participants

Nicotine Regulation for Dual Users of E-cigarettes and Cigarettes

University of Vermont

NCT06614504

RECRUITING Phase 3 200 participants

Cannabis-Tobacco Co-Use Treatment Study

Medical University of South Carolina

NCT06883162

RECRUITING NA 200 participants

Smoking Cessation Behavioral Treatment Study

University of Missouri-Columbia

NCT03948893

RECRUITING 200 participants

Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics

Yale University

NCT06624137

RECRUITING Phase 2 120 participants

Cannabidiol for Reducing Cigarette Use

University of California, Los Angeles

NCT06218056

RECRUITING NA 108 participants

Smoking Cessation CM for Veterans With or at Risk for Cancer

VA Office of Research and Development

NCT06432985

RECRUITING Phase 4 105 participants

E-cigarette Cessation in Adults Who Co-use Cannabis

Medical University of South Carolina

NCT06688539

RECRUITING Phase 4 80 participants

Beta-Adrenergic Modulation of Drug Cue Reactivity

University of Oklahoma

NCT05587361

RECRUITING NA 75 participants

Quit-Smoking Study for Native Hawaiians

University of Hawaii

NCT07075575

RECRUITING NA 70 participants

A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder

Massachusetts General Hospital

NCT06609902

RECRUITING Phase 2 66 participants

5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Johns Hopkins University

NCT05452772

RECRUITING Phase 2 64 participants

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

University of California, Los Angeles

NCT06617312

RECRUITING Phase 2 50 participants

Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD

VA Office of Research and Development

NCT05723588

RECRUITING Phase 1 50 participants

Oral Cannabidiol for Tobacco Cessation

Johns Hopkins University

NCT05445804

RECRUITING NA 44 participants

Low Intensity Focused Ultrasound for Tobacco Use Disorder: High Resolution Targeting of the Human Insula

Washington D.C. Veterans Affairs Medical Center

NCT06405074

RECRUITING NA 36 participants

Contingency Management for Veteran Smokers Undergoing Major Elective Surgery

University of California, San Francis

NCT06678672

RECRUITING Phase 2 30 participants

An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction

University of Missouri-Columbia

NCT03713424

RECRUITING Phase 2 30 participants

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

Yale University

NCT06006143

ACTIVE NOT RECRUITING Phase 4 631 participants

Varenicline and Combined NRT for Smoking Cessation

M.D. Anderson Cancer Center

NCT02271919

ACTIVE NOT RECRUITING Phase 2 400 participants

Omega-3 Fatty Acids for Smoking Cessation in Pregnancy

Vanderbilt University Medical Center

NCT04417595

ACTIVE NOT RECRUITING NA 338 participants

Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer

M.D. Anderson Cancer Center

NCT00542373

ACTIVE NOT RECRUITING NA 220 participants

Nicotine Replacement Therapy Prescribing and Lung Cancer Screening in Hospitalized Patients

Medical University of South Carolina

NCT07164404

ACTIVE NOT RECRUITING NA 120 participants

Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study

Florida International University

NCT07192601

ACTIVE NOT RECRUITING NA 85 participants

Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation

M.D. Anderson Cancer Center

NCT02697227

ACTIVE NOT RECRUITING NA 26 participants

A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

M.D. Anderson Cancer Center

NCT05044546

ACTIVE NOT RECRUITING NA 24 participants

Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment

M.D. Anderson Cancer Center

NCT03519451

COMPLETED Phase 2 1,864 participants

Tobacco Zero: Interactive Tobacco Education for Teens

Deschutes Research

NCT00670995

COMPLETED Phase 2 1,683 participants

Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Oregon Research Institute

NCT00820495

COMPLETED NA 943 participants

Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder

US Department of Veterans Affairs

NCT00118534

COMPLETED NA 878 participants

Financial Incentives for Smoking Cessation

University of Pennsylvania

NCT00128375

COMPLETED Phase 4 837 participants

Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence

University of Rochester

NCT00178685

COMPLETED Phase 1 775 participants

Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

Brown University

NCT02232737

COMPLETED Phase 1 775 participants

Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers

University of Vermont

NCT02250664

COMPLETED Phase 2 646 participants

Pharmacogenetics, Emotional Reactivity and Smoking

M.D. Anderson Cancer Center

NCT00507728

COMPLETED Phase 2 391 participants

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

University of Minnesota

NCT00710034

COMPLETED 350 participants

Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

University of Minnesota

NCT01673711

COMPLETED Phase 2 326 participants

Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

University of Vermont

NCT04092101

COMPLETED Phase 2 243 participants

Selegiline Patch for Treatment of Nicotine Dependence

Stanford University

NCT01330030

COMPLETED Phase 2 235 participants

Innovative Interventions for Smoking Cessation

University of Minnesota

NCT01050569

COMPLETED NA 213 participants

Cognitive Training for Nicotine Dependence

University of Pennsylvania

NCT01252966

COMPLETED Phase 3 200 participants

Naltrexone Augmentation of Nicotine Patch Therapy - 1

National Institute on Drug Abuse (NIDA)

NCT00218153

COMPLETED Phase 2 172 participants

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

National Institute on Drug Abuse (NIDA)

NCT00129272

COMPLETED NA 165 participants

A Facebook Intervention for Young Sexual and Gender Minority Smokers

University of California, San Francis

NCT03259360

COMPLETED NA 162 participants

Intensive Intervention for Smokers - 6

University of California, San Francis

NCT00217984

COMPLETED NA 158 participants

Innovative Digital Therapeutic for Smoking Cessation

My Digital Study

NCT03694327

COMPLETED Phase 2 152 participants

Reduction of Smoking in Cardiac Disease Patients

National Institute on Drug Abuse (NIDA)

NCT00469885

COMPLETED NA 148 participants

Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers

Ohio State University Comprehensive Cancer Center

NCT02439255

COMPLETED Phase 2 142 participants

Treatment of Smoking Among Individuals With PTSD

University of Pennsylvania

NCT00937235

COMPLETED Phase 2 138 participants

Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use

National Institute on Drug Abuse (NIDA)

NCT00218270

COMPLETED NA 122 participants

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

University of Minnesota

NCT01497158

COMPLETED NA 104 participants

Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

University of Minnesota

NCT00711100

COMPLETED NA 100 participants

Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

NYU Langone Health

NCT02628964

COMPLETED Phase 2 98 participants

Effect of Galantamine on Short-term Abstinence

University of Pennsylvania

NCT01669538

COMPLETED NA 84 participants

Examining a Text Message Intervention for Smoking Cessation

The Miriam Hospital

NCT01166464

COMPLETED NA 73 participants

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Rutgers, The State University of New Jersey

NCT01308736

COMPLETED NA 63 participants

Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking

University of Missouri-Columbia

NCT03960138

COMPLETED Phase 1 58 participants

Persistence-Targeted Smoking Cessation

Rutgers, The State University of New Jersey

NCT01654107

COMPLETED NA 58 participants

Text Message Support to Prevent Smoking Relapse

Miami University

NCT02968095

COMPLETED NA 56 participants

Medicinal Nicotine for Preventing Cue Induced Craving

University of Minnesota

NCT02347605

COMPLETED Phase 4 52 participants

A Comparison of Bupropion SR and Placebo for Smoking Cessation

University of Maryland, Baltimore

NCT00176449

COMPLETED NA 47 participants

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

University of Minnesota

NCT03402243

COMPLETED Phase 2 41 participants

Progesterone for Smoking Relapse Prevention Following Delivery

Yale University

NCT01972464

COMPLETED Phase 2 40 participants

Tobacco Approach Avoidance Training for Adolescent Smokers-1

Yale University

NCT01625767

COMPLETED Phase 2 28 participants

N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers

University of Chicago

NCT00967005

COMPLETED Phase 1 25 participants

Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3

New York State Psychiatric Institute

NCT00136786

COMPLETED Early Phase 1 21 participants

Reduced Nicotine Cigarette Purchasing Decisions

Johns Hopkins University

NCT04999644

COMPLETED Phase 1 20 participants

Lorcaserin for Preventing Weight Gain Among Smokers

Mayo Clinic

NCT02393547

COMPLETED Phase 1 15 participants

Brain Imaging in Tobacco Smokers During a Quit Attempt

Johns Hopkins University

NCT04055467

COMPLETED Phase 4 14 participants

Varenicline Effects In Schizophrenic Smokers

Nathan Kline Institute for Psychiatric Research

NCT00548470

COMPLETED NA 10 participants

Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy

Hartford Hospital

NCT00888979

COMPLETED Phase 2

Role of Metabolites in Nicotine Dependence (2) - 5

National Institute on Drug Abuse (NIDA)

NCT00000288

COMPLETED Phase 2

Progesterone Treatment in Female Smokers - 12

National Institute on Drug Abuse (NIDA)

NCT00000295

COMPLETED Phase 3

Non-Nicotine Agents for Smoking Cessation

US Department of Veterans Affairs

NCT00108537

COMPLETED Phase 2

Role of Metabolites in Nicotine Dependence (1) - 1

National Institute on Drug Abuse (NIDA)

NCT00000284

Phase Distribution

PhaseTrial count
Early Phase 1 8
Phase 2 26
Phase 3 3
Phase 4 6

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

Reading the Tobacco Use Disorder Trial Landscape

ClinicalTrials.gov lists 75 US studies indexed under Tobacco Use Disorder, and 19 of those are currently open to recruitment — roughly 25% 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 Tobacco Use Disorder shows 9 late-stage studies (Phase 3 and Phase 4 combined) alongside 34 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 Tobacco Use Disorder is led by National Institute on Drug Abuse (NIDA) with 7 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 75 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 Tobacco Use Disorder?

PlainTrial tracks 75 US clinical trials for Tobacco Use Disorder, of which 19 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Tobacco Use Disorder?

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

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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 · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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