12 completed, 3 unknown, 2 terminated. 6 Phase 3, 5 Phase 2, 4 Not applicable, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 4, Terminated 1, Unknown 1 |
| Phase 2 | 5 | Completed 3, Terminated 1, Unknown 1 |
| Not applicable | 4 | Completed 3, Unknown 1 |
| Phase 1 | 2 | Completed 1, Terminated 1 |
| Phase 4 | 1 | Completed 1 |
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 |
|---|---|---|---|---|---|---|
| Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product - Smoking Cessation, Harm Reduction | Phase 3 | Completed | Rose Research Center, LLC | 150 | 2024-08-29 | 2026-02-06 |
| Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product - Smoking Cessation, Harm Reduction | Phase 3 | Terminated | Rose Research Center, LLC | 4 | 2023-12-27 | 2025-03-30 |
| 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 |
| Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study Access to all varieties of on! 4mg nicotine pouches (Berry, Citrus, Cinnamon, Wintergreen, Mint, Coffee, and Original), Access to Original on! 4mg nicotine pouches, Non-Flavored then complete flavor on! nicotine pouches - Cigarette Smoking Behavior | Not applicable | Unknown | Altria Client Services LLC | 400 | 2023-09-11 | 2024-07-11 |
| Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette BIDI Stick e-cigarette - Smoking Cessation | Not applicable | Completed | Rose Research Center, LLC | 25 | 2023-02-14 | 2024-03-19 |
| The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette Bupropion, Zonisamide, Placebo bupropion - Smoking Cessation | Phase 3 | Completed | Rose Research Center, LLC | 180 | 2021-12-14 | 2026-02-06 |
| Study of EMB-001 as a Potential Smoking Cessation Treatment EMB-001 - Tobacco Use Disorder | Phase 1 / Phase 2 | Terminated | Embera NeuroTherapeutics, Inc. | 16 | 2021-06-10 | 2023-08-09 |
| Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment EMB-01 - Smoking Cessation, Tobacco Use Disorder | Phase 2 / Phase 3 | Unknown | Rose Research Center, LLC | 25 | 2021-05-19 | 2021-05-28 |
| A Comparison of Exhaled Carbon Monoxide Measurements Using the iCOquit Smokerlyzer and Vitalograph Breath CO Monitor vs Carboxyhemoglobin From Venous Samples While Validating a Mobile Research Application Smoking, Cigarette | Completed | Rose Research Center, LLC | 30 | 2021-03-22 | 2022-01-13 | |
| Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes Zonisamide, Bupropion, Halo G6 e-cigarette - Smoking Cessation | Phase 3 | Completed | Rose Research Center, LLC | 26 | 2020-05-27 | 2022-04-13 |
| Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders Behavioral and pharmacological support to reduce combustible tobacco use. - Tobacco Use | Unknown | Rose Research Center, LLC | 100 | 2020-01-30 | 2021-09-28 | |
| Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction Varenicline, e-cigarette - Smoking Cessation, Harm Reduction | Phase 2 / Phase 3 | Completed | Rose Research Center, LLC | 25 | 2019-11-19 | 2022-02-24 |
| Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes JUUL - Smoking Cessation, Harm Reduction | Not applicable | Completed | Rose Research Center, LLC | 50 | 2019-08-26 | 2025-04-20 |
| Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment Varenicline Pill, Hydroxyzine Pill - Smoking Cessation, Stress | Phase 4 | Completed | Rose Research Center, LLC | 26 | 2019-06-17 | 2023-03-03 |
| Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use Smoking research cigarettes with e-cigarette, Nicotine discrimination thresholds - Nicotine Addiction, Cigarette Smoking | Phase 2 | Completed | Rose Research Center, LLC | 150 | 2019-05-01 | 2022-01-14 |
| A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers JUUL 5%, Virginia Tobacco, ENDS product - Tobacco Use, Nicotine Dependence, Other Tobacco Product | Not applicable | Completed | Juul Labs, Inc. | 30 | 2018-08-09 | 2021-06-14 |
| Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers Sublingual tablet 4 mg versus Nicorette Lozenge 4mg - Tobacco Use Disorder, Cigarette Smoking | Phase 1 | Completed | Friends Research Institute, Inc. | 24 | 2017-05-25 | 2017-12-04 |
Smoking Cessation (11) · Harm Reduction (6) · Tobacco Use Disorder (6) · Cigarette Smoking (5) · Vaping (5) · Tobacco Use (3) · Nausea (1) · Parasomnias (1) · Smoking (1) · Substance-Related Disorders (1) · Tobacco Smoking (1) · Tobacco Use Cessation (1)
Electronic Nicotine Delivery Systems (4) · Bupropion (2) · Chewing Gum (2) · Nicotine (2) · Nicotine Chewing Gum (2) · Tobacco Use Cessation Devices (2) · Varenicline (2) · Zonisamide (2) · Administration, Sublingual (1) · Coffee (1) · Cycloserine (1) · Fruit (1) · Hydroxyzine (1) · Metyrapone (1) · Oxazepam (1)
United States (17)
Bruce McCarthy, MD (1) · Frank J Vocci, Ph.D. (1) · Hui Cheng, PhD (1) · Jed E Rose, Ph.D. (1) · Jed Rose, MD (1) · Kevin McGirr, MS, MPH (1)
PMID 37230961, PMID 38905632, PMID 39075535
R01DA042541 (1)