Back to resultsA Trial of E-cigarettes in Current Cigarette Smokers
Primary Purpose
Smoking, Nicotine Dependence, Nicotine Dependence, Other Tobacco Product
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electronic cigarette
cigarette group
Sponsored by
About this trial
This is an interventional other trial for Smoking focused on measuring smoking, nicotine, tobacco products, electronic cigarette
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
cigarette group
electronic cigarette
Arm 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.
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.
Outcomes
Primary Outcome Measures
Uptake of Electronic Nicotine Delivery Systems (ENDS)
% of participants by group used e-cigarettes in week 16
Independent Purchase of an ENDs Product
% of participants by group who purchased an ENDs product on their own during the study
% Quit Attempts
% of participants who made any quit attempt during study
Point Prevalence Abstinence
% of participants with CO-verified cigarette abstinence at study week 16
Secondary Outcome Measures
Full Information
NCT ID
NCT02357173
First Posted
October 3, 2014
Last Updated
March 7, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02357173
Brief Title
A Trial of E-cigarettes in Current Cigarette Smokers
Official Title
A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Nicotine Dependence, Nicotine Dependence, Other Tobacco Product
Keywords
smoking, nicotine, tobacco products, electronic cigarette
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cigarette group
Arm Type
Active Comparator
Arm 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.
Arm Title
electronic cigarette
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
electronic cigarette
Other Intervention Name(s)
Blu ecigs
Intervention Type
Other
Intervention Name(s)
cigarette group
Primary Outcome Measure Information:
Title
Uptake of Electronic Nicotine Delivery Systems (ENDS)
Description
% of participants by group used e-cigarettes in week 16
Time Frame
study week 16
Title
Independent Purchase of an ENDs Product
Description
% of participants by group who purchased an ENDs product on their own during the study
Time Frame
study enrollment to study week 16
Title
% Quit Attempts
Description
% of participants who made any quit attempt during study
Time Frame
study enrollment to study week 16
Title
Point Prevalence Abstinence
Description
% of participants with CO-verified cigarette abstinence at study week 16
Time Frame
week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Carpenter, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of E-cigarettes in Current Cigarette Smokers
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