A Trial of E-cigarettes in Current Cigarette Smokers

A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Nicotine Dependence; Nicotine Dependence, Other Tobacco Product
• Intervention / Treatment: Other: cigarette group; Other: electronic cigarette

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: cigarette group
Experimental: 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.	Other: electronic cigarette; Other Names: Blu ecigs

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Matthew J Carpenter, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: smoking; electronic cigarette; nicotine; tobacco products
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: Pro00035634; 1R21DA037407-01 (U.S. NIH Grant/Contract)