Treatment of Smoking Lapses and Relapses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Smoking Lapses and Relapses

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: nicotine patch, experimental use
* Drug: nicotine patch, labeled use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nicotine patch, experimental use<br>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<br>* 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.<br>* Other names: Nicoderm Clear 7 mg;|
| Active Comparator: nicotine patch, labeled use<br>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<br>* 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.<br>* Other names: Nicoderm Clear 7 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence | 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 | To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal. | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NRT, nicotine dependence, smoking cessation, lapse, relapse, tobacco, nicotine patch, nicotine replacement therapy