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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

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.

Condition or disease Intervention/treatment Phase
Smoking Nicotine Dependence Nicotine Dependence, Other Tobacco Product Other: electronic cigarette Other: cigarette group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Trial of E-cigarettes: Natural Uptake, Patterns and Impact of Use
Study Start Date : November 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

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 Name: Blu ecigs




Primary Outcome Measures :
  1. Uptake of Electronic Nicotine Delivery Systems (ENDS) [ Time Frame: study week 16 ]
    % of participants by group used e-cigarettes in week 16

  2. 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

  3. % Quit Attempts [ Time Frame: study enrollment to study week 16 ]
    % of participants who made any quit attempt during study

  4. Point Prevalence Abstinence [ Time Frame: week 16 ]
    % of participants with CO-verified cigarette abstinence at study week 16



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357173


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Matthew J Carpenter, PhD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02357173    
Other Study ID Numbers: Pro00035634
1R21DA037407-01 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2015    Key Record Dates
Results First Posted: April 4, 2018
Last Update Posted: April 4, 2018
Last Verified: November 2016
Keywords provided by Medical University of South Carolina:
smoking
nicotine
tobacco products
electronic cigarette
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders