drugset / Trial / NCT03000387
Personalized Dosing of Nicotine Replacement (NRT to Effect)
Phase 4
Completed
211 enrolled
Centre for Addiction and Mental Health
Canadian Cancer Society (CCS) · collabOttawa Heart Institute Research Corporation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting success in those who do not respond to a standard dose of NRT (21mg).
Timeline
- Start
- 2018-01-23
- Primary completion
- 2023-02-27
- Completion
- 2023-12-11
Publications
- Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
- Zawertailo L, Hendershot CS, Tyndale RF, Le Foll B, Samokhvalov AV, Thorpe KE, Pipe A, Reid RD, Selby P. Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. Trials. 2020 Jun 29;21(1):592. doi: 10.1186/s13063-020-04532-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 7 mg | Other |
| Subject | Nicotine | Unknown | 14 mg | Other |
| Subject | Nicotine | Unknown | 21 mg | Other |