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Treatment of Smoking Lapses and Relapses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01807871
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 28, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Hughes, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: nicotine patch, experimental use Drug: nicotine patch, labeled use Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Smoking Lapses and Relapses
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: nicotine patch, experimental use
Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.
Drug: nicotine patch, experimental use
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.
Other Names:
  • Nicoderm Clear 21 mg
  • Nicoderm Clear 14 mg
  • Nicoderm Clear 7 mg

Active Comparator: nicotine patch, labeled use
Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.
Drug: nicotine patch, labeled use
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.
Other Names:
  • Nicoderm Clear 21 mg
  • Nicoderm Clear 14 mg
  • Nicoderm Clear 7 mg




Primary Outcome Measures :
  1. Point-prevalent Abstinence at 4 Months [ Time Frame: 4 months after the quit date ]
    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".


Secondary Outcome Measures :
  1. Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence [ Time Frame: 4 months after the quit date ]
    To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.

  2. Adverse Drug Effects [ Time Frame: Up to 12 weeks ]
    To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807871


Locations
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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John R Hughes, MD University of Vermont

Publications of Results:
Other Publications:

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Responsible Party: John Hughes, Faculty Department of Psychiatry, University of Vermont
ClinicalTrials.gov Identifier: NCT01807871     History of Changes
Other Study ID Numbers: M12-113
R01CA165080 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2013    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: October 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Hughes, University of Vermont:
nicotine dependence
smoking cessation
lapse
relapse
tobacco
nicotine patch
nicotine replacement therapy
NRT
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action