A Trial of E-cigarettes in Current Cigarette Smokers

Not Applicable

Completed

• Conditions: Smoking; Nicotine Dependence; Nicotine Dependence, Other Tobacco Product
• Interventions: Other: cigarette group; Other: electronic cigarette

• Registration Number: NCT02357173
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.

Detailed Description

Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22).

Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-03
• Study Start: 2014-11
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Primary Completion: 2016-05
• Status Verified: 2016-11
• Study Completion: 2017-07
• Results First Submitted: 2017-09-29
• Results First Submitted QC: 2018-03-07
• Last Update Submitted: 2018-03-07
• Results First Posted: 2018-04-04
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• age 18+
• current smoker of at least 5 cigarettes per day for at least 1 year
• at least some concern for health effects of smoking
• having an easily accessible email address

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Exclusion Criteria

• past six month use of any e-cigarette
• lifetime ever purchase of any e-cigarette
• recent history of cardiovascular distress (heart attack in past year; arrhythmia; uncontrolled hypertension)
• recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus
• pregnant or breastfeeding
• any major current psychiatric impairment, including current alcohol/drug abuse/dependence
• use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days
• current use of any smoking cessation medications
• current enrollment in a smoking cessation treatment study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cigarette group	cigarette group	This group (1/3 of the sample) will not receive electronic cigarettes to sample and will continue smoking their regular cigarettes as much or as little as they would like.
electronic cigarette	electronic cigarette	This group (2/3 of the sample) will be given electronic cigarettes for a 3-week period, to use as much or as little as they would like.

Primary Outcome Measures

Name	Time	Method
Uptake of Electronic Nicotine Delivery Systems (ENDS)	study week 16	% of participants by group used e-cigarettes in week 16
Independent Purchase of an ENDs Product	study enrollment to study week 16	% of participants by group who purchased an ENDs product on their own during the study
% Quit Attempts	study enrollment to study week 16	% of participants who made any quit attempt during study
Point Prevalence Abstinence	week 16	% of participants with CO-verified cigarette abstinence at study week 16

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States