18 completed, 3 terminated, 2 active not recruiting, 2 not yet recruiting. 9 Phase 3, 8 Phase 1, 6 Phase 2, 4 Not applicable, 4 Phase 4.
Follow cytisine: new trials by email Literature Review of cytisine trials Research Report on cytisine
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 |
|---|---|---|---|---|---|---|
| Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes Cytisinicline, Placebo, Behavioral Support - Vaping Cessation | Phase 3 | Not yet recruiting | Achieve Life Sciences | 800 | 2026-05-15 | 2026-02-06 |
| Smoking Harm Reduction Using E-cigarettes and Cytisine E-cigarette e-liquid, Cytisine - Tobacco Smoking, Harm Reduction | Not applicable | Not yet recruiting | Centre for Addiction and Mental Health | 6000 | 2026-05-01 | 2026-03-19 |
| Cytisine vs Nicotine Replacement Therapy Cytisine, Nicotine replacement therapy (NRT) - Tobacco Dependence, COPD Asthma | Not applicable | Enrolling by invitation | Ottawa Hospital Research Institute | 200 | 2025-11-04 | 2026-03-17 |
| Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge), Cytisine, Varenicline (Champix) - Tobacco | Phase 4 | Recruiting | Ottawa Heart Institute Research Corporation | 150 | 2025-04-30 | 2026-03-05 |
| 12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence Cytisinicline and exercise, Cytisinicline - Smoking Cessation | Phase 4 | Unknown | Maimónides Biomedical Research Institute of Córdoba | 150 | 2025-01-01 | 2024-09-04 |
| 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 |
| Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers Cytisinicline - Smoking Cessation, Vaping Cessation | Phase 3 | Completed | Achieve Life Sciences | 479 | 2024-05-28 | 2025-11-26 |
| Web-based Smoking Intervention as an add-on to Routine Smoking Cessation Clinical Treatment POLSIS, routine service delivery(Nicotine Replacement Theraphy, Cytisine) - Smoking Cessation | Not applicable | Completed | Ege University | 208 | 2024-05-01 | 2025-04-25 |
| PeRiopEratiVE SmokiNg CessaTion Trial Cytisine, Video Messaging - Smoking (Tobacco) Addiction, Smoking Cessation | Phase 3 | Active not recruiting | Population Health Research Institute | 1720 | 2024-01-15 | 2024-10-03 |
| Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers Cytisinicline - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 30 | 2023-08-08 | 2023-10-18 |
| Cytisine for Smoking Cessation Cytisine, Placebo - Tobacco Use Disorder, Alcohol Use Disorder | Phase 4 | Completed | Centre for Addiction and Mental Health | 20 | 2023-02-08 | 2026-02-27 |
| Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose cytisinicline - Renal Impairment | Phase 1 | Completed | Achieve Life Sciences | 44 | 2023-01-10 | 2025-07-11 |
| Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers Cytisinicline, Placebo, Moxifloxacin - Smoking Cessation | Phase 1 | Completed | Achieve Life Sciences | 27 | 2022-10-17 | 2023-05-18 |
| A Study of Cytisinicline for Vaping Cessation in Adult Smokers cytisinicline, Placebo, Behavioral support - Vaping, E-Cig Use | Phase 2 | Completed | Achieve Life Sciences | 160 | 2022-07-13 | 2026-01-14 |
| Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation (Cess@Tion) Cytisine, Nicotine delivered via an e-cigarette, Cytisine plus nicotine delivered via an e-cigarette - Smoking Cessation | Phase 3 | Completed | University of Auckland, New Zealand | 807 | 2022-05-05 | 2024-12-19 |
| Cytisine Compared to Combination NRT in Relapsed Smokers Cytisine, Nicoderm C-Q Transdermal Product, Nicorette Lozenge Product - Smoking Cessation, Coronary Artery Disease | Not applicable | Terminated | Ottawa Heart Institute Research Corporation | 13 | 2022-03-14 | 2023-12-08 |
| Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy Cytisine, Nicotine Replacement Therapy (NRT) - Nicotine Addiction | Phase 4 | Completed | Loma Linda University | 1307 | 2022-01-27 | 2024-09-19 |
| A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers Cytisinicline, Placebo, Behavioral support - Smoking Cessation | Phase 3 | Completed | Achieve Life Sciences | 792 | 2022-01-20 | 2026-01-14 |
| A Study of Cytisinicline for Smoking Cessation in Adult Smokers Cytisinicline, Placebo, Behavioral support - Smoking Cessation | Phase 3 | Completed | Achieve Life Sciences | 810 | 2020-10-13 | 2026-01-15 |
| Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting Varenicline, Cytisine - Smoking Cessation | Phase 3 | Completed | University of Zagreb | 352 | 2020-07-14 | 2022-11-03 |
Showing 20 of 29. Sign in to see all of them.
Smoking Cessation (23) · Tobacco Use Disorder (5) · Smoking (3) · Vaping (3) · Behavior, Addictive (2) · Inflammation (2) · Motor Activity (2) · Alcohol Drinking (1) · Alcoholism (1) · Cigarette Smoking (1) · Coronary Artery Disease (1) · Coronary Disease (1) · HIV Infections (1) · Harm Reduction (1) · Lung Neoplasms (1)
Achieve Life Sciences (13) · University of Auckland, New Zealand (3) · Centre for Addiction and Mental Health (2) · Ottawa Heart Institute Research Corporation (2) · Boston Medical Center (1) · Ege University (1) · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (1) · Loma Linda University (1) · Maimónides Biomedical Research Institute of Córdoba (1) · Ottawa Hospital Research Institute (1) · Population Health Research Institute (1) · University of California, Los Angeles (1) · University of Zagreb (1)
United States (6) · Canada (5) · Portugal (4) · New Zealand (3) · United Kingdom (3) · Croatia (1) · Italy (1) · Mongolia (1) · Russia (1) · Slovenia (1) · Spain (1) · Turkey (Türkiye) (1)
Marlene Fonseca, MD (3) · Annelize Koch, MD (2) · Daniel Cain, Vice-President Clinical Research (2) · Julie Ball (2) · Natalie Walker, PhD (2) · Andrew Pipe, MD (1) · Bernard Le Foll (1) · Davaalkham Dambadarjaa, MD (1) · Ezanul Abd Wahab, MD (1) · Flavia Kessler Borges, Dr. (1) · Hrvoje Tiljak, PhD (1) · Janez Rifel, PhD (1) · Jeffrey H Samet, MA, MA, MPH (1) · Jeffrey M Ashbruner, PhD, MPH (1) · Mitchell Nides, PhD (1)
PMID 40962497, PMID 30526213, PMID 33761149, PMID 35930287, PMID 37432430, PMID 37697327, PMID 38709500, PMID 39876021, PMID 40257755, PMID 40894854
2016 (1), 2017 (1), 2018 (1), U01AA020780 (1)