drugset / Trial / NCT01622998
Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation
Phase 4
Completed
303 enrolled
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves long-term rates of smoking cessation in patients motivated to quit smoking when compared to patients using the standard transdermal NRT patch protocol. The following hypothesis will be tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be higher for the titrated, self-directed NRT group compared to the standard NRT treatment group.
Timeline
- Start
- 2011-01
- Primary completion
- 2014-08
- Completion
- 2014-09
Publications
- Background Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004 Jan;99(1):29-38. doi: 10.1111/j.1360-0443.2004.00540.x.
- Background Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
- Background Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 4 mg | Other |
| Subject | Nicotine | Unknown | 7 mg | Other |
| Subject | Nicotine | Unknown | 14 mg | Other |
| Subject | Nicotine | Unknown | 21 mg | Other |
Indications
No indication recorded.