A Trial of E-cigarettes in Current Cigarette Smokers

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Nicotine Dependence; Nicotine Dependence, Other Tobacco Product; Smoking

Treatments: Other: electronic cigarette; Other: cigarette group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02357173

Pro00035634

1R21DA037407-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

cigarette group

Active Comparator group

Description:

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.

Treatment:

Other: cigarette group

electronic cigarette

Experimental group

Description:

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.

Treatment:

Other: electronic cigarette