Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
A Pilot Study to Test the Feasibility of a Randomized Controlled Trial of E-cigarettes as Harm Reduction Tools Among People Who Smoke and Previously Failed to Quit With Pharmacotherapy.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Smith Tracy T, Ferreira Anna, Wahlquist Amy E, Cummings K Michael, Rojewski Alana M, McClure Erin A, Toll Benjamin A, Carpenter Matthew J
Аннотация
INTRODUCTION: We conducted a pilot study to test the feasibility of a future randomized controlled trial comparing e-cigarettes to traditional pharmacotherapy among people who smoke daily, were motivated to quit, and failed to quit within the past 5 years using pharmacotherapy.
AIMS AND METHODS: Eligible participants were assigned to either: (1) an e-cigarette (n = 20) or (2) combination nicotine replacement therapy (NRT; patches and lozenges; n = 10). Participants received 5 weeks of product and selected a quit date 1 week later. Assessments were completed weekly, and electronic diaries were completed each day. As a pilot randomized controlled trial, outcomes focus on effect sizes and not statistical significance.
RESULTS: Participants in the e-cigarette and NRT groups had a mean age of 51 (SD = 13) and 50 (SD = 10) years old, were 55% and 60% female, and were 15% and 0% nonWhite, respectively. At least 90% of participants completed each weekly assessment and 77% of participants completed at least 80% of daily diaries. Mean cigarettes smoked per day reduced from 18 (SD = 6.2) to 2.4 (SD = 4.4) per day in the e-cigarette group and 16.5 (SD = 8.5) to 4.9 (SD = 5.9) per day in the NRT group. Rates of biochemically confirmed 7-day point-prevalence abstinence at the end of treatment were numerically, but not statistically, higher in the e-cigarette group than the NRT group (35% vs. 10%, OR = 4.8, 95% CI = 0.5 to 46.5).
CONCLUSIONS: Among current daily cigarette smokers who have previously tried to quit and failed with standard pharmacotherapies, the provision of an e-cigarette is a feasible intervention. A larger adequately powered trial is warranted.
IMPLICATIONS: This pilot study suggests that e-cigarettes may serve as an acceptable harm reduction intervention for people who smoke but cannot quit smoking with traditional pharmacotherapy, however, adequately powered randomized controlled trials are needed.
AIMS AND METHODS: Eligible participants were assigned to either: (1) an e-cigarette (n = 20) or (2) combination nicotine replacement therapy (NRT; patches and lozenges; n = 10). Participants received 5 weeks of product and selected a quit date 1 week later. Assessments were completed weekly, and electronic diaries were completed each day. As a pilot randomized controlled trial, outcomes focus on effect sizes and not statistical significance.
RESULTS: Participants in the e-cigarette and NRT groups had a mean age of 51 (SD = 13) and 50 (SD = 10) years old, were 55% and 60% female, and were 15% and 0% nonWhite, respectively. At least 90% of participants completed each weekly assessment and 77% of participants completed at least 80% of daily diaries. Mean cigarettes smoked per day reduced from 18 (SD = 6.2) to 2.4 (SD = 4.4) per day in the e-cigarette group and 16.5 (SD = 8.5) to 4.9 (SD = 5.9) per day in the NRT group. Rates of biochemically confirmed 7-day point-prevalence abstinence at the end of treatment were numerically, but not statistically, higher in the e-cigarette group than the NRT group (35% vs. 10%, OR = 4.8, 95% CI = 0.5 to 46.5).
CONCLUSIONS: Among current daily cigarette smokers who have previously tried to quit and failed with standard pharmacotherapies, the provision of an e-cigarette is a feasible intervention. A larger adequately powered trial is warranted.
IMPLICATIONS: This pilot study suggests that e-cigarettes may serve as an acceptable harm reduction intervention for people who smoke but cannot quit smoking with traditional pharmacotherapy, however, adequately powered randomized controlled trials are needed.