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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

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE February 6, 2015
Results First Submitted Date  ICMJE September 29, 2017
Results First Posted Date  ICMJE April 4, 2018
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • Uptake of Electronic Nicotine Delivery Systems (ENDS) [ Time Frame: study week 16 ]
    % of participants by group used e-cigarettes in week 16
  • Independent Purchase of an ENDs Product [ Time Frame: study enrollment to study week 16 ]
    % of participants by group who purchased an ENDs product on their own during the study
  • % Quit Attempts [ Time Frame: study enrollment to study week 16 ]
    % of participants who made any quit attempt during study
  • Point Prevalence Abstinence [ Time Frame: week 16 ]
    % of participants with CO-verified cigarette abstinence at study week 16
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • uptake of e-cigarettes [ Time Frame: study enrollment through end of 3-month follow up ]
    Uptake will be defined as: trial (first time use), repeat trial (second time use), first time buyer (independent purchase), and repeat buyer.
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • smoking reduction [ Time Frame: study enrollment through end of 3-month follow up ]
    reduction in cigarettes per day
  • quit attempts [ Time Frame: study enrollment through end of 3-month follow up ]
    self-defined attempts to stop smoking cigarettes forever
  • 24-hr quit attempts [ Time Frame: study enrollment through end of 3-month follow up ]
    self-defined attempts to stop smoking cigarettes forever lasting at least 24 hours
  • floating abstinence [ Time Frame: study enrollment through end of 3-month follow up ]
    abstinence from cigarettes at any point in study
  • point prevalence abstinence [ Time Frame: study enrollment through end of 3-month follow up ]
    biologically-verified abstinence from cigarettes at any given study visit
  • continuous abstinence [ Time Frame: study enrollment through end of 3-month follow up ]
    biologically-verified abstinence from cigarettes over multiple study visits
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of E-cigarettes in Current Cigarette Smokers
Official Title  ICMJE A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Smoking
  • Nicotine Dependence
  • Nicotine Dependence, Other Tobacco Product
Intervention  ICMJE
  • Other: electronic cigarette
    Other Name: Blu ecigs
  • Other: cigarette group
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Other: electronic cigarette
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
68
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2015)
60
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02357173
Other Study ID Numbers  ICMJE Pro00035634
1R21DA037407-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Matthew J Carpenter, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP