Treatment of Smoking Lapses and Relapses
2 other identifiers
interventional
701
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
March 28, 2017
CompletedOctober 13, 2017
September 1, 2017
2.9 years
March 4, 2013
February 8, 2017
September 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Point-prevalent Abstinence at 4 Months
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No".
4 months after the quit date
Secondary Outcomes (2)
Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence
4 months after the quit date
Adverse Drug Effects
Up to 12 weeks
Study Arms (2)
nicotine patch, experimental use
EXPERIMENTALParticipants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
nicotine patch, labeled use
ACTIVE COMPARATORParticipants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
Interventions
nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
Eligibility Criteria
You may qualify if:
- at least 18 years old
- daily smoker of 10 or more cigarettes per day for at least 1 year
- state they plan to probably or definitely quit smoking in the next month
- have a home or cell phone
- willing to use nicotine patch
- good command of written and spoken English
- weigh at least 100 pounds
- US citizen or permanent resident alien
You may not qualify if:
- use of non-cigarette tobacco in the last month
- use of a smoking cessation medication or smoking cessation counseling in the last month
- medical contraindication to use of patch
- other person in household already in our study
- previously a participant in the study
- currently pregnant or breast feeding
- plan to become pregnant in the next 6 months
- regularly works the overnight shift
- use of electronic cigarettes in the last month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Vermontlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Vermont
Burlington, Vermont, 05401, United States
Related Publications (10)
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.
PMID: 15626567BACKGROUNDStead 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.
PMID: 18253970BACKGROUNDPierce 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.
PMID: 12215133BACKGROUNDBader 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.
PMID: 18845621BACKGROUNDWest 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.
PMID: 11400998BACKGROUNDPerkins 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.
PMID: 11270510BACKGROUNDHughes 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.
PMID: 16042638BACKGROUNDSussman 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.
PMID: 19570247BACKGROUNDHughes 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.
PMID: 28756042RESULTTheodoulou 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.
PMID: 37335995DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Hughes
- Organization
- University of Vermont
Study Officials
- PRINCIPAL INVESTIGATOR
John R Hughes, MD
University of Vermont
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty Department of Psychiatry
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 8, 2013
Study Start
March 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
October 13, 2017
Results First Posted
March 28, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share