Clinical trial NCT01807871: Treatment of Smoking Lapses and Relapses
Official title: Treatment of Smoking Lapses and Relapses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: nicotine dependence
smoking cessation
lapse
relapse
tobacco
nicotine patch
nicotine replacement therapy
NRT
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-08
Enrollment: 701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Point-prevalent Abstinence at 4 Months
timeFrame: 4 months after the quit date
Secondary outcomes:
measure: Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence
timeFrame: 4 months after the quit date
measure: Adverse Drug Effects
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: John R Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22. doi: 10.1016/j.amepre.2004.09.007.
citation: Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.
citation: Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002 Sep 11;288(10):1260-4. doi: 10.1001/jama.288.10.1260.
citation: Bader P, McDonald P, Selby P. An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Tob Control. 2009 Feb;18(1):34-42. doi: 10.1136/tc.2008.025635. Epub 2008 Oct 9.
citation: West R, Shiffman S. Effect of oral nicotine dosing forms on cigarette withdrawal symptoms and craving: a systematic review. Psychopharmacology (Berl). 2001 May;155(2):115-22. doi: 10.1007/s002130100712.
citation: Perkins KA, Fonte C, Meeker J, White W, Wilson A. The discriminative stimulus and reinforcing effects of nicotine in humans following nicotine pretreatment. Behav Pharmacol. 2001 Feb;12(1):35-44. doi: 10.1097/00008877-200102000-00004.
citation: Hughes JR, Carpenter MJ. The feasibility of smoking reduction: an update. Addiction. 2005 Aug;100(8):1074-89. doi: 10.1111/j.1360-0443.2005.01174.x.
citation: Sussman S. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting. Tob Induc Dis. 2002 Jan 15;1(1):35-81. doi: 10.1186/1617-9625-1-1-35.
citation: Hughes JR, Solomon LJ, Peasley-Miklus CE, Callas PW, Fingar JR. Effectiveness of continuing nicotine replacement after a lapse: A randomized trial. Addict Behav. 2018 Jan;76:68-81. doi: 10.1016/j.addbeh.2017.07.023. Epub 2017 Jul 14.