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OpenTrials
Completed

NCT Number: NCT02357173

A Trial of E-cigarettes in Current Cigarette Smokers

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Cigarette

Other

Other names: Blu ecigs

cigarette group

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 6, 2015
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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