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A Trial of E-cigarettes in Current Cigarette Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357173
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Smoking
Nicotine Dependence
Nicotine Dependence, Other Tobacco Product
Interventions Other: electronic cigarette
Other: cigarette group
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 16 mg Electronic Nicotine Delivery Systems (ENDS) 24 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Hide Arm/Group Description

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
Period Title: Overall Study
Started 25 21 22
Completed 19 15 16
Not Completed 6 6 6
Arm/Group Title 16 mg Electronic Nicotine Delivery Systems (ENDS) 24 mg Electronic Nicotine Delivery Systems (ENDS) Control Group Total
Hide Arm/Group Description

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose. Total of all reporting groups
Overall Number of Baseline Participants 25 21 22 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 21 participants 22 participants 68 participants
43.3  (14.4) 40.9  (12.3) 42.3  (14.2) 42.2  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 22 participants 68 participants
Female
18
  72.0%
9
  42.9%
14
  63.6%
41
  60.3%
Male
7
  28.0%
12
  57.1%
8
  36.4%
27
  39.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 25 participants 21 participants 22 participants 68 participants
White
14
  56.0%
10
  47.6%
13
  59.1%
37
  54.4%
Black or African American
10
  40.0%
11
  52.4%
9
  40.9%
30
  44.1%
Multiracial
1
   4.0%
0
   0.0%
0
   0.0%
1
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 21 participants 22 participants 68 participants
25 21 22 68
1.Primary Outcome
Title Uptake of Electronic Nicotine Delivery Systems (ENDS)
Hide Description % of participants by group used e-cigarettes in week 16
Time Frame study week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Hide Arm/Group Description:

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
Overall Number of Participants Analyzed 21 25 22
Measure Type: Number
Unit of Measure: percentage of participants
57.14 32 13.64
2.Primary Outcome
Title Independent Purchase of an ENDs Product
Hide Description % of participants by group who purchased an ENDs product on their own during the study
Time Frame study enrollment to study week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Hide Arm/Group Description:

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
Overall Number of Participants Analyzed 21 25 22
Measure Type: Number
Unit of Measure: percentage of participants
57 28 14
3.Primary Outcome
Title % Quit Attempts
Hide Description % of participants who made any quit attempt during study
Time Frame study enrollment to study week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Hide Arm/Group Description:

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
Overall Number of Participants Analyzed 21 25 22
Measure Type: Number
Unit of Measure: percentage of participants
47.6 40 27.3
4.Primary Outcome
Title Point Prevalence Abstinence
Hide Description % of participants with CO-verified cigarette abstinence at study week 16
Time Frame week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Hide Arm/Group Description:

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
Overall Number of Participants Analyzed 21 25 22
Measure Type: Number
Unit of Measure: percentage of participants
9.5 4.0 4.6
Time Frame study week 2 to study week 16
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Hide Arm/Group Description

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.

Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group.

This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose.
All-Cause Mortality
24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/25 (0.00%)      0/22 (0.00%)    
Hide Serious Adverse Events
24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/25 (0.00%)      0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
24 mg Electronic Nicotine Delivery Systems (ENDS) 16 mg Electronic Nicotine Delivery Systems (ENDS) Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/21 (52.38%)      9/25 (36.00%)      8/22 (36.36%)    
Gastrointestinal disorders       
nausea   5/21 (23.81%)  6 3/25 (12.00%)  3 4/22 (18.18%)  4
Mouth/throat irritation   3/21 (14.29%)  3 3/25 (12.00%)  3 5/22 (22.73%)  5
heartburn   1/21 (4.76%)  1 0/25 (0.00%)  0 2/22 (9.09%)  2
General disorders       
Trouble sleeping   1/21 (4.76%)  1 1/25 (4.00%)  1 3/22 (13.64%)  4
other   2/21 (9.52%)  2 0/25 (0.00%)  0 0/22 (0.00%)  0
Nervous system disorders       
headache   3/21 (14.29%)  3 1/25 (4.00%)  1 4/22 (18.18%)  7
dizziness or lightheadness   0/21 (0.00%)  0 2/25 (8.00%)  2 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders       
cough   5/21 (23.81%)  5 6/25 (24.00%)  7 4/22 (18.18%)  6
Indicates events were collected by systematic assessment
  • small sample size
  • 1st generation e-cigarette device
  • no placebo group
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Matthew Carpenter
Organization: Medical University of South Carolina
Phone: 843-876-2436
EMail: carpente@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02357173    
Other Study ID Numbers: Pro00035634
1R21DA037407-01 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2014
First Posted: February 6, 2015
Results First Submitted: September 29, 2017
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018