Overview

This trial is active, not recruiting.

Conditions smoking, nicotine dependence, nicotine dependence, other tobacco product
Treatments electronic cigarette, cigarette group
Sponsor Medical University of South Carolina
Collaborator National Institute on Drug Abuse (NIDA)
Start date November 2014
End date May 2016
Trial size 68 participants
Trial identifier NCT02357173, 1R21DA037407-01, Pro00035634

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
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.
cigarette group
(Experimental)
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.
electronic cigarette Blu ecigs

Primary Outcomes

Measure
uptake of e-cigarettes
time frame: study enrollment through end of 3-month follow up
amount and frequency of e-cigarette use
time frame: study enrollment through end of 3-month follow up
use of e-cigarette within and not within smoking restrictions
time frame: study enrollment through end of 3-month follow up
contextual antecedents of e-cigarette vs. cigarette use
time frame: study enrollment through end of 3-month follow up
nicotine/cotinine replacement and changes in carbon monoxide (CO).
time frame: study enrollment through end of 3-month follow up

Secondary Outcomes

Measure
smoking reduction
time frame: study enrollment through end of 3-month follow up
quit attempts
time frame: study enrollment through end of 3-month follow up
24-hr quit attempts
time frame: study enrollment through end of 3-month follow up
floating abstinence
time frame: study enrollment through end of 3-month follow up
point prevalence abstinence
time frame: study enrollment through end of 3-month follow up
continuous abstinence
time frame: study enrollment through end of 3-month follow up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
Principal investigator Matthew J Carpenter, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.