A Pilot Study to Test the Feasibility for a Randomized Controlled Trial of E-cigarettes as Harm Reduction Tools Among People Who Smoke and Previously Failed to Quit with Pharmacotherapy.

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.

Methods: Eligible participants were assigned to either: 1) an e-cigarette (n=20) or 2) combination nicotine replacement therapy (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 effects 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% non-white, 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=0.5-46.5).

Conclusions: Among current daily cigarette smokers who have previously tried to quit and failed using standard pharmacotherapies, 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 who cannot quit smoking with traditional pharmacotherapy, but adequately powered randomized controlled trials are needed.