Abstract
IMPORTANCE: Although little cigars and cigarillos (LCCs) are common combustible tobacco products, the effects of LCC warning labels on behavioral outcomes remain untested. OBJECTIVE: To evaluate the effects of LCC graphic health warnings (GHWs) on promoting LCC quitting intentions and behaviors. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included 1029 adult LCC users from a Qualtrics online panel who were randomized to (1) LCC GHWs (n = 339), (2) existing US Food and Drug Administration (FDA) text-only warnings (n = 346), or (3) no stimulus control (n = 344). Participants accessed messages via email from May 1 to August 31, 2023, and completed surveys each day, with repeated exposure to LCC packages based on study condition. INTERVENTIONS: Participants were exposed to 6 new LCC GHWs or FDA text-only cigar warnings 18 times over 3 weeks. The control group received no visual stimuli. MAIN OUTCOMES AND MEASURES: The primary outcome was postintervention quit intentions, measured by a score ranging from 1 (low quit intention) to 4 (high quit intention). Secondary outcomes were the proportion having forgone or butted out (ie, extinguished an LCC that they had already lit) LCCs in the past week and the proportion having attempted to quit or reduced LCC use in the past week. Data were analyzed on an intent-to-treat basis using mixed-model analysis of variance and were adjusted for baseline behaviors. RESULTS: Among the 1029 participants, the mean (SD) age was 43.9 (11.3) years, 578 (56.2%) were men, and 767 (74.5%) were users of both types of LCCs. Retention to trial end was high across all arms (LCC GHWs, 307 of 339 [90.6%]; FDA text-only warnings, 316 of 346 [91.3%]; and control group, 308 of 344 [89.5%]). Participants in the LCC GHW group reported significantly higher postintervention (and change from preintervention to postintervention) quit intentions (mean score, 2.9 [95% CI, 2.8-3.0]) compared with FDA text-only participants (mean, 2.5 [95% CI, 2.4-2.6]) and control (mean, 2.6 [95% CI, 2.4-2.7]) (P < .001). The mean proportion of participants reporting quit attempts after the intervention was significantly higher for participants in the LCC GHW group compared with participants in the text-only group (0.4 [95% CI, 0.4-0.5] vs 0.3 [95% CI, 0.2-0.3]). Participants in the LCC GHW group were more likely than those in the text-only group to forgo or butt out LCCs (adjusted estimate [SE]: forgoing little cigars, 0.12 [0.03]; forgoing cigarillos, 0.13 [0.03]; butting out little cigars, 0.07 [0.04]; butting out cigarillos, 0.07 [0.03]). No significant difference occurred in the change (from pre to post) in quit attempts between the LCC GHW and control groups. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that LCC GHWs were effective in increasing quit intentions and reducing LCC use behaviors. Current FDA warnings appear insufficient. Findings support enhanced GHWs on LCC packages to address significant public health gaps, aligned with global tobacco control strategies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05849051.