Randomized controlled trial examining the adjunctive use of nicotine lozenges with MyLastDip: An eHealth smokeless tobacco cessation intervention

Introduction: Promising Web-based interventions for smokeless tobacco cessation have emerged. We describe a randomized controlled trial (RCT) testing the relative benefits of adding the nicotine lozenge as an adjunct to the MyLastDip Web-based smokeless tobacco cessation intervention. Methods: 407 smokeless tobacco users who wanted to quit were recruited, screened online, and randomly assigned to one of two conditions: (a) the interactive MyLastDip Web-based intervention (Web Only; n = 202), or (b) the website plus the offer of nicotine lozenges (Web. +. Lozenge; n = 205). MyLastDip program content is grouped according to three sequential frames: preparing to quit, quitting, and staying quit. If a participant reported a lapse then the program would provide tailored content on lessons learned and starting over ("retooling"). The primary outcome was 7-day point prevalence tobacco abstinence measured at follow-up assessments that occurred 3. months and 6. months post-enrollment. Results: Assessment completion rates were 71.5% at 3. months, 72.9% at 6. months, and 65.1% for both 3 and 6. months, and did not differ by condition. Using Intent to Treat analyses, the Web. +. Lozenge condition was associated with a significantly higher 7-day point prevalence tobacco abstinence rate than the Web Only condition at 3. months (43.4% vs. 29.7%, p = .004), at the combined 3 and 6. month assessment of repeated point prevalence (35.6% vs. 23.3%, p = .007), but not at 6. months (44.4% vs. 35.1%, p = .057). Similar results were obtained for smokeless tobacco abstinence. Participants reported being satisfied with their programs and the Web. +. Lozenge condition participants visited the MyLastDip program more often (p<. .001). A composite engagement measure of the number and duration of program visits was positively related to 6-month tobacco abstinence (p = .009). Conclusions: Consistent with previous research, the MyLastDip Web-based tobacco cessation intervention encouraged long-term levels of tobacco and smokeless tobacco abstinence. The addition of nicotine lozenges significantly improved both participant engagement and self-reported 7-day point prevalence tobacco abstinence at 3. months and when considering 3- and 6-month repeated point prevalence tobacco abstinence.