Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation

Introduction: Relatively few treatment programs have been developed specifically for smokeless tobacco (ST) users who want to quit. Their results suggest that self-help materials, telephone counseling, and nicotine lozenges are efficacious. This study provides the first direct examination of the separate and combined effects of telephone counseling and lozenges. Methods: We recruited ST users online (N = 1067) and randomly assigned them to 1 of 3 conditions: (a) a lozenge group (n = 356), who were mailed 4-mg nicotine lozenges; (b) a coach calls group (n = 354), who were offered 3 coaching phone calls; or (c) a lozenge + coach calls group (N = 357), who received both lozenges and coaching calls. Additionally, all participants were mailed self-help materials. Self-reported tobacco abstinence was assessed at 3 and 6 months after randomization. Results: Complete-case and intention-to-treat (ITT) analyses for all tobacco abstinence were performed at 3 months, 6 months, and both 3 and 6 months (repeated point prevalence). ITT analyses revealed a highly similar result: the lozenge + coach calls condition was significantly more successful in encouraging tobacco abstinence than either the lozenge group or the coach calls group, which did not differ. Conclusions: Combining nicotine lozenges and phone counseling significantly increased tobacco abstinence rates compared with either intervention alone, whereas coach calls and lozenges were equivalent. The study confirms the high tobacco abstinence rates for self-help ST cessation interventions and offers guidance to providing tobacco treatment to ST users.