NCT02628964

Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.

Detailed description

This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks

Conditions

• Tobacco Use Disorder
• Smoking

Interventions

Type	Name	Description
DEVICE	e-cigarettes	Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2015-12-11
• Last updated: 2020-02-24
• Results posted: 2020-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study