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Treatment of Smoking Lapses and Relapses

Phase 4
18 Years
Open (Enrolling)
Smoking Cessation

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Trial Information

Treatment of Smoking Lapses and Relapses


To test our hypothesis that among smokers who lapse while using nicotine replacement therapy
(NRT), those randomized to continue NRT post-lapse will be more likely to be point-prevalent
abstinent at 4-month follow-up than those randomized to not continue NRT post-lapse.

To test whether the amount of use of NRT 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 NRT use on abstinence.

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


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,

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.

Inclusion Criteria:

- at least 18 years old

- daily smoker of greater than 10 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

Exclusion Criteria:

- use of non-cigarette tobacco in the last month

- use of a smoking cessation medication 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Point-prevalent abstinence at 4 months

Outcome Description:

To test the hypothesis that among smokers who lapse while using nicotine replacement therapy, those randomized to continue nicotine replacement will be more likely to be point-prevalent abstinent at 4 month follow-up than those randomized to not continue nicotine replacement post lapse.

Outcome Time Frame:

4 months after the quit date

Safety Issue:


Principal Investigator

John R Hughes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

September 2015

Related Keywords:

  • Smoking Cessation
  • nicotine dependence
  • smoking cessation
  • lapse
  • relapse
  • tobacco
  • nicotine patch
  • nicotine replacement therapy
  • NRT
  • Smoking



University Of VermontBurlington,, Vermont  05403