137 completed, 15 recruiting, 13 terminated, 8 withdrawn. 182 Phase 2, 21 Phase 1, 21 Phase 3.
Follow Smoking Cessation: new trials by email Literature Review of Smoking Cessation trials Research Report on Smoking Cessation
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers Nicotine Mint Oro Dispersible Tablet (Nic ODT), Placebo Oro Dispersible Tablet (Placebo ODT) - Smoking Cessation, Nicotine Replacements Therapy | Phase 2 | Recruiting | McNeil AB | 280 | 2026-10-05 | 2026-10-23 |
| THCV Treatment for Smokers Δ9-Tetrahydrocannabivarin (oral gummy), Matched Placebo (oral gummy) - Tobacco Use Disorder, Smoking Cessation | Phase 2 | Not yet recruiting | University of California, Los Angeles | 32 | 2026-10-01 | 2026-08-04 |
| A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients Naltrexone hydrochloride, Bupropion Hydrochloride Extended-release, Cognitive-Behavioral Therapy - Obesity, Smoking Cessation | Phase 1 / Phase 2 | Not yet recruiting | Medical University of South Carolina | 64 | 2026-09-01 | 2026-07-08 |
| Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation Varenicline (VAR), Nicotine lozenge (NRT), Smartphone intervention with adherence components (COMBO-A) - Smoking Cessation | Phase 2 | Recruiting | University of Oklahoma | 496 | 2026-07-21 | 2026-11-09 |
| Enhancing Smoking Cessation for African American People Everywhere ESCAPE app + NRT, quiSTART app + NRT, Control (CTRL) - ESCAPE Intervention+NRT, quitSTART Intervention+NRT | Phase 2 | Recruiting | University of Houston | 300 | 2026-06-30 | 2026-07-13 |
| Multi-Site Trial of Tirzepatide for Smoking Cessation Tirzepatide, Placebo - Smoking Cessation, Smoking Behaviors | Phase 2 | Recruiting | University of Southern California | 300 | 2026-06-05 | 2026-07-17 |
| A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation Non-invasive vagus nerve stimulator plus nicotine replacement patches, nicotine replacement patches - Smoking Cessation | Phase 2 / Phase 3 | Recruiting | Mayo Clinic | 150 | 2026-06-04 | 2026-09-25 |
| Accelerated dTMS Smoking Cessation Bilateral deep accelerated repetitive transcranial magnetic stimulation - Tobacco Use Disorder, Addiction Nicotine | Phase 2 | Recruiting | Waypoint Centre for Mental Health Care | 40 | 2026-02-24 | 2026-04-21 |
| Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis Standard Varenicline Dosing (1 mg BID), Bupropion 150 mg twice daily, Increased Varenicline Dosing (1mg TID) - Pancreatitis, Chronic, Pancreatitis, Acute | Phase 2 | Withdrawn | Mayo Clinic | 2025-11-06 | 2026-07-07 | |
| Empowering Cessation ACS South Region Empowering Cessation for the ACS South - Smoking Cessation | Phase 2 / Phase 3 | Recruiting | University of Oklahoma | 400 | 2025-08-14 | 2026-05-11 |
| Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity Cytisinicline, Placebo Oral Capsule - Smoking Cessation, Tobacco Use Disorder | Phase 2 | Recruiting | University of California, Los Angeles | 64 | 2024-12-05 | 2025-12-03 |
| Cannabidiol for Reducing Cigarette Use Cannabidiol (CBD) 800 mg, Placebo - Tobacco Use Disorder, Tobacco Smoking | Phase 2 | Recruiting | University of California, Los Angeles | 120 | 2024-10-31 | 2026-04-13 |
| The Potential of Kava in Enabling Tobacco Cessation - Its Holistic Effects in Managing Stress and Insomnia Associated With Abstinence Placebo, AB-free kava - Smoking | Phase 2 | Recruiting | University of Florida | 76 | 2024-06-06 | 2026-01-27 |
| Dyadic Financial Incentive Treatments for Dual Smoker Couples Financial Incentive Treatment (FIT) - Smoking, Cigarette | Phase 2 | Recruiting | University of Oklahoma | 900 | 2024-01-18 | 2026-04-29 |
| CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes Regular Nicotine patch and lozenge dose, Augmented Nicotine patch and lozenge dose - Smoking Cessation, Electronic Cigarette Use | Phase 2 | Completed | Medical University of South Carolina | 46 | 2023-12-05 | 2025-11-26 |
| Evaluating Smoking Cessation Interventions for PWH in South Africa Varenicline, Nicotine patch, Nicotine gum - Smoking Cessation, HIV | Phase 2 / Phase 3 | Recruiting | Johns Hopkins University | 660 | 2023-11-27 | 2026-10-19 |
| 5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder Psilocybin, Niacin - Tobacco Use Disorder | Phase 2 | Recruiting | Johns Hopkins University | 66 | 2023-11-01 | 2026-06-29 |
| Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine d-cycloserine, Juul e-cigarette - Smoking Cessation, Harm Reduction | Phase 2 | Completed | Rose Research Center, LLC | 25 | 2023-10-20 | 2026-01-20 |
| Overcoming Nicotine Dependence to Enable Quitting Nicotine Replacement Therapy (NRT) Sampling, Practice Quitting (PQ) Counseling, Motivational Interviewing (MI) Counseling - Tobacco Use, Smoking Cessation | Phase 1 / Phase 2 | Recruiting | Rush University Medical Center | 780 | 2023-03-24 | 2026-09-09 |
| Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO) NFL-101, Placebo - Smoking Cessation, Nicotine Dependence | Phase 2 | Completed | NFL Biosciences SAS | 34 | 2023-02-21 | 2023-10-19 |
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Tobacco Use Disorder (56) · Smoking (47) · Cigarette Smoking (23) · Behavior, Addictive (8) · Tobacco Smoking (7) · Tobacco Use Cessation (7) · Schizophrenia (5) · Tobacco Use (5) · Lung Neoplasms (4) · Psychotic Disorders (4) · Pulmonary Disease, Chronic Obstructive (4) · Vaping (4) · Alcohol Drinking (3) · Bipolar Disorder (3)
Behavior (182) · Health Behavior (182) · Mental Disorders (64) · Chemically-Induced Disorders (59) · Substance-Related Disorders (58) · Tobacco Use (28) · Smoking (24) · Tobacco Smoking (21) · Pathological Conditions, Signs and Symptoms (16) · Lung Diseases (10) · Respiratory Tract Diseases (10) · Signs and Symptoms (10) · Compulsive Behavior (8) · Impulsive Behavior (8) · Body Weight (7)
Tobacco Use Cessation Devices (34) · Varenicline (32) · Nicotine Replacement Therapy (22) · Nicotine (19) · Bupropion (14) · Cognitive Behavioral Therapy (8) · Nicotine Chewing Gum (8) · Behavior Therapy (5) · Tobacco Products (4) · cytisine (4) · lorcaserin (4) · Counseling (3) · Exercise (3) · Naltrexone (3) · Sugars (3)
Yale University (10) · National Institute on Drug Abuse (NIDA) (8) · Medical University of South Carolina (7) · University of Oklahoma (7) · Pfizer (5) · Duke University (4) · Mayo Clinic (4) · The University of Texas Health Science Center, Houston (4) · Centre for Addiction and Mental Health (3) · GlaxoSmithKline (3) · Johns Hopkins University (3) · McNeil AB (3) · Rose Research Center, LLC (3) · University of California, Los Angeles (3) · University of Florida (3)
United States (138) · Canada (8) · France (5) · Germany (4) · Italy (3) · Sweden (3) · United Kingdom (3) · Australia (2) · Belgium (2) · Denmark (2) · Netherlands (2) · South Africa (2) · Switzerland (2) · Czechia (1) · Finland (1)
Jed E Rose, Ph.D. (6) · Sherry A McKee, PhD (6) · Dorothy Hatsukami, Ph.D. (2) · Elisabeth Kruse, PhD (2) · Judith J Prochaska, PhD, MPH (2) · Luba Yammine, PhD (2) · Maurizio Fava, MD (2) · Ramzi Salloum, PhD (2) · Ryan T Hurt, MD, PhD (2) · Yves Donazzolo, MD (2) · Adam M Leventhal, PhD (1) · Ajna Hamidovic, PharmD, MS (1)
PMID 37142273, PMID 37230961, PMID 34611902, PMID 15534159, PMID 17692720, PMID 18381502, PMID 18513462, PMID 18686184, PMID 18823182, PMID 20334673, PMID 20537810, PMID 20565161, PMID 20934835, PMID 21221531, PMID 21270788, PMID 21543158, PMID 21652735, PMID 21928117, PMID 21939867, PMID 22097928, PMID 22219220, PMID 22229310, PMID 22373002, PMID 22761006, PMID 22882805, PMID 22898118, PMID 22993168, PMID 23177384, PMID 23216646, PMID 23507358, PMID 23536105, PMID 23603206, PMID 24075893, PMID 24811751, PMID 24894625, PMID 25005652, PMID 25192771, PMID 25361769, PMID 25622198, PMID 25646352, PMID 25727442, PMID 25762749, PMID 26457385, PMID 26476459, PMID 26638126, PMID 27349898, PMID 27535024, PMID 27815511, PMID 28825423, PMID 29054128
P50DA027840 (5), P50AA015632 (3), R01AA015596 (2), R34DA043751 (2), U01DA019378 (2), UH3TR000958 (2), 2005 (1), 2008 (1), 2016 (1), 2017 (1), K01MD015295 (1), K23DA019950 (1), K23DA037299 (1), K23DA064898 (1), N01CN00034 (1)