Treatment of Smoking Lapses and Relapses
Summary
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
Timeline
- Start
- 2013-03
- Primary completion
- 2016-02
- Completion
- 2016-02
Outcome
Missed primary endpoint
paper did not have a greater incidence of 7-day abstinence at 4months (primary outcome) PMID 28756042 ↗
registry analysis (superiority test); Nicotine Patch, Experimental Use vs Nicotine Patch, Labeled Use; p = 0.48; Chi-squared NCT01807871 ↗
Publications
- Background Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22. doi: 10.1016/j.amepre.2004.09.007.
- Background Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.
- Background Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002 Sep 11;288(10):1260-4. doi: 10.1001/jama.288.10.1260.
- Background Bader P, McDonald P, Selby P. An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Tob Control. 2009 Feb;18(1):34-42. doi: 10.1136/tc.2008.025635. Epub 2008 Oct 9.
- Background West R, Shiffman S. Effect of oral nicotine dosing forms on cigarette withdrawal symptoms and craving: a systematic review. Psychopharmacology (Berl). 2001 May;155(2):115-22. doi: 10.1007/s002130100712.
- Background Perkins KA, Fonte C, Meeker J, White W, Wilson A. The discriminative stimulus and reinforcing effects of nicotine in humans following nicotine pretreatment. Behav Pharmacol. 2001 Feb;12(1):35-44. doi: 10.1097/00008877-200102000-00004.
- Background Hughes JR, Carpenter MJ. The feasibility of smoking reduction: an update. Addiction. 2005 Aug;100(8):1074-89. doi: 10.1111/j.1360-0443.2005.01174.x.
- Background Sussman S. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting. Tob Induc Dis. 2002 Jan 15;1(1):35-81. doi: 10.1186/1617-9625-1-1-35.
- Results Hughes JR, Solomon LJ, Peasley-Miklus CE, Callas PW, Fingar JR. Effectiveness of continuing nicotine replacement after a lapse: A randomized trial. Addict Behav. 2018 Jan;76:68-81. doi: 10.1016/j.addbeh.2017.07.023. Epub 2017 Jul 14.
- 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 | 7 mg | Other |
| Subject | Nicotine | Unknown | 14 mg | Other |
| Subject | Nicotine | Unknown | 21 mg | Other |
Indications
No indication recorded.