Using nicotine gum to assist non-daily smokers in quitting: A randomized clinical trial

Introduction: Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smokefor nicotine and have trouble quitting, but tend to smoke in particular situations. This study testedthe 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 nicotinegum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcomewas 6-month biochemically verified continuous abstinence; analyses also examined 14-day pointprevalence 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 andbaseline smoking, and considered several potential moderators of treatment effects.Results: Nicotine gum did not significantly improve outcomes on any measure. Biochemicallyverified 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 NicotineDependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorlyon active gum on some outcomes. Gum use was low, starting at 1 gum per day on average anddeclining over time.Conclusions: Nicotine gum (2 mg), used intermittently, did not improve cessation rates amongITS, including those demonstrating some degree of dependence.Implications: Nicotine replacement has been extensively tested with daily smokers, especiallythose 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 theoreticallyand 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 areneeded for ITS, especially those with some degree of dependence.