Pilot randomised controlled trial of an e-cigarette and tobacco use intervention for hospitalised youth.

Abstract

Introduction: We sought to evaluate preliminary efficacy and implementation outcomes of an e-cigarette and tobacco cessation intervention for hospitalised youth in the USA.

Methods: We conducted a pilot randomised controlled trial at a paediatric hospital with 3-month follow-up from August 2023 to December 2024. Hospitalised youth (14-21 years) with self-reported past 30-day e-cigarette use were eligible. Exclusions included severe medical/psychiatric illness, cognitive impairment and inability to communicate in English. Intervention entailed health education, motivational interviewing counselling, quit planning, nicotine replacement therapy (NRT) and phone booster sessions. Control entailed brief advice and quit programme referral. The primary outcome was self-reported past 30-day e-cigarette abstinence at 3 months with biochemical confirmation with intention-to-treat (ITT) sensitivity analysis. Implementation outcomes included acceptability, feasibility and fidelity.

Results: In 144 hospitalised youth enrolled, the mean age was 16.2 years (SD: 1.3) and 62% were female. At 3 months there was no difference in past 30-day e-cigarette abstinence between arms (intervention 43% vs control 42%; p=0.91). In ITT analysis we found the OR of abstinence was OR 0.77 (95% CI 0.27 to 2.19, p=0.62) in the intervention versus control. Mean fidelity score was 43 (SD: 3; out of 50). All intervention participants (n=96) completed the initial in-person intervention, 49% made a quit plan, of those 23% were prescribed NRT. Most (89%) were somewhat/very satisfied with the intervention.

Conclusions: Our study is among the first to demonstrate promising implementation but not efficacy of an e-cigarette cessation intervention in hospitalised youth. Future work is needed to enhance intervention efficacy in this population.

Trial registration number: NCT05936099.