Treatment of Smoking Lapses and Relapses
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/15/2017 |
| Start Date: | March 2013 |
| End Date: | February 2016 |
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.
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.
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.
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.
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
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