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A Factorial Randomized Clinical Trial of Nicotine Replacement Therapy and Treatment Recommendations to Quit Versus
Elias M Klemperer1,2, Marc Jerome P Feinstein1,2, Katya Marsh1
1Department of Psychiatry, College of Medicine, University of Vermont, Burlington, VT, USA.
Introduction:
Multiple tobacco product use has increased markedly in the United States, especially dual use of cigarettes and e-cigarettes among young adults. Little is known regarding nicotine replacement therapy (NRT) for young adult dual users, or whether to recommend quitting versus continuing e-cigarettes during smoking cessation treatment.
Methods:
This 2 × 2 factorial trial randomized 396 young adult dual users (aged 18-29; ≥ 5 cigarettes/day; used e-cigarettes on ≥ 10 of past 30 days) to receive 12 weeks of combination NRT versus No NRT to quit smoking, plus text-based treatment recommendations to Quit versus Continue E-cigarettes. The primary outcome was self-reported end-of-treatment 7-day point-prevalence abstinence (PPA) from cigarettes; a secondary outcome was end-of-treatment 30-day PPA from cigarettes.
Results:
Participants were 26.0 (SD = 6.8) years old, 52.8% female, and 26.5% non-white. At week 12, NRT increased 7-day PPA (NRT = 50.5% versus No NRT = 39.9%; OR = 1.54, 95% CI = 1.03, 2.29), but neither treatment recommendation (Quit E-cigarettes = 48.0% versus Continue E-cigarettes = 42.4%; OR = 1.25, 95% CI = 0.84, 1.85) nor the NRT-by-treatment recommendation interaction were significant. The direction and magnitude of main effects for 30-day PPA at week 12 were similar to 7-day PPA, but the NRT-by-treatment recommendation interaction was significant (p = .04): smoking cessation was greatest for the NRT plus Quit E-cigarettes condition (47.1%) versus NRT plus Continue E-cigarettes (28.1%); No NRT plus Quit E-cigarettes (29.2%); and No NRT plus Continue E-cigarettes (30.4%) conditions (all p < .05).
Conclusions:
NRT is effective in promoting early smoking cessation among young adult dual users. Secondary findings indicate that pairing NRT with support to quit both products could enhance the effects on prolonged cigarette abstinence.
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