Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial

Abstract

Background: Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts.

Methods: Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment.

Results: Compared with PQA intervention, nicotine therapy sampling was associated with a significantly higher incidence of any quit attempt (49% vs 40%; relative risk [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit attempt (43% vs 34%; 1.3; 1.1-1.5). Nicotine therapy sampling was marginally more likely to promote floating abstinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month point prevalence abstinence rates were no different between groups (16% vs 14%; 1.2; 0.9-1.6).

Conclusion: Nicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt.

Trial registration: clinicaltrials.gov Identifier: NCT00706979.

Figure 1

Recruitment flow. ITT indicates intent to treat; NT, nicotine therapy; and PQA, practice quit attempt. *Exclusion criteria are not mutually exclusive.

Figure 2

Rates of any quit attempt (relative risk, 1.2; 95% CI, 1.1–1.4) and 24-hour quit attempt (1.3; 1.1–1.5) (A) and rates of floating abstinence (7-day point prevalence abstinence at any time during the study) (1.3; 1.0–1.7) and 7-day point prevalence abstinence at the final follow-up assessment (week 26) (1.2; 0.9–1.6) (B). NT indicates nicotine therapy; PQA, practice quit attempt.