Using Nicotine Gum to Assist Nondaily Smokers in Quitting: A Randomized Clinical Trial

Author:

Shiffman Saul1,Scholl Sarah M1,Mao Jason2,Ferguson Stuart G3ORCID,Hedeker Donald4,Primack Brian5,Tindle Hilary A67

Affiliation:

1. Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA

2. Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA

3. College of Health & Medicine, University of Tasmania, Hobart, TAS, Australia

4. Department of Public Health Sciences, University of Chicago, Chicago, IL, USA

5. Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

6. Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA

7. Veterans Affairs Tennessee Valley Healthcare System, Geriatric Research Education and Clinical Centers (GRECC), Nashville, TN, USA

Abstract

Abstract Introduction Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit. Methods ITS (smoking 4–27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects. Results Nicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58–3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time. Conclusions Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence. Implications Nicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS’ smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence.

Funder

National Institute on Drug Abuse

National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Public Health, Environmental and Occupational Health

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