Treatment of Smoking Lapses and Relapses

September 12, 2017 updated by: John Hughes, University of Vermont
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives:

To test our hypothesis that among the subset of the 770 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.

To test whether the amount of patch use 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.

To test whether the incidence of adverse events (AEs) during post-lapse patch use is minimal.

Purpose:

Over the counter (OTC) NRT is, by far, the most common treatment for smoking cessation in the United States (Cokkinides, Ward, Jemel, & Thun, 2005). Over 80% of those using OTC NRT will lapse (Stead, Perera, Bullen, Mant, & Lancaster, 2008). One possible reason for this high rate of relapse is that NRT package labeling states "do not use if you continue to smoke", and the majority of smokers believe this means it is best to stop using NRT upon a lapse; e.g., the only survey on real-world use of NRT during a lapse episode found that 77% of smokers discontinued NRT after a lapse (Pierce & Gilpin, 2002). The investigators and others (Bader, McDonald, & Selby, 2009) believe continuing NRT during a lapse episode will a) relieve craving and withdrawal (West & Shiffman, 2001), b) block the reinforcing effects of smoking (Perkins, Fonte, Meeker, White, & Wilson, 2001; Rose & Behm, 2004), c) help smokers smoke less (Hughes & Carpenter, 2005), and d) increase self-efficacy, all of which should help smokers re-establish abstinence.

Study design:

The investigators are proposing a parallel groups randomized controlled trial (RCT) in which all treatment and monitoring occur via phone, and medication via mail. The investigators will recruit about 770 smokers to receive phone counseling before and after the quit date and nicotine patches for 10 weeks after the quit date. At study entry, smokers will be randomized to a "Continue NRT" or a "Discontinue NRT" condition. The Continue NRT participants will be advised that, if they lapse, they should continue NRT. Smokers randomized to the Discontinue NRT condition will be advised that, if they lapse, they should discontinue NRT use. The messages will also include rationales. Messages will be delivered several times via written material, Interactive Voice Response (IVR) messages and during phone counseling. Participants will record cigs/day nightly via a phone-based IVR system for 10 weeks. If the IVR detects a lapse during the first 10 weeks of the study, it will encourage the participant to re-establish abstinence as soon as possible and repeat the condition-appropriate message about post-lapse NRT use. After the 10-week treatment period, the investigators will use monthly questionnaires (online or paper) to assess recent smoking, cigs/day, NRT use, and other stop-smoking medications.

Subject selection:

Men and women, minorities and children over 18 will be included. Pregnant and breastfeeding women, women who plan to become pregnant and those at risk for AEs from NRT will be excluded. Our goal is to recruit a sample of the same gender, ethnicity/race prevalence as that of US smokers interested in quitting; i.e. 52% men, 78% White/Non-Hispanic, 11% Black, 8% Hispanic and 3% other ethnicities/races (Hughes & Callas, 2010). The investigators do not have data on which to estimate the percent who will be children between ages 18-21 but most studies suggest very few young smokers are interested in formal treatment (Sussman, 2002).

Number of subjects:

The investigators have chosen an initial inclusion of 770 smokers to obtain a sample size of 490 smokers who lapse on NRT.

Study Type

Interventional

Enrollment (Actual)

701

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
4 months after the quit date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months after the quit date
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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-113
  • R01CA165080 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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