NCT02357173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 4, 2018

Completed
Last Updated

April 4, 2018

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

October 3, 2014

Results QC Date

September 29, 2017

Last Update Submit

March 7, 2018

Conditions

SmokingNicotine DependenceNicotine Dependence, Other Tobacco Product

Keywords

smokingnicotinetobacco productselectronic cigarette

Outcome Measures

Primary Outcomes (4)

  • Uptake of Electronic Nicotine Delivery Systems (ENDS)

    % of participants by group used e-cigarettes in week 16

    study week 16

  • Independent Purchase of an ENDs Product

    % of participants by group who purchased an ENDs product on their own during the study

    study enrollment to study week 16

  • % Quit Attempts

    % of participants who made any quit attempt during study

    study enrollment to study week 16

  • Point Prevalence Abstinence

    % of participants with CO-verified cigarette abstinence at study week 16

    week 16

Study Arms (2)

cigarette group

ACTIVE COMPARATOR

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

electronic cigarette

EXPERIMENTAL

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

Interventions

electronic cigaretteOTHER
Also known as: Blu ecigs
electronic cigarette
cigarette groupOTHER
cigarette group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

SmokingTobacco Use DisorderVaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Limitations and Caveats

* small sample size * 1st generation e-cigarette device * no placebo group

Results Point of Contact

Title
Dr. Matthew Carpenter
Organization
Medical University of South Carolina
carpente@musc.edu
843-876-2436

Study Officials

  • Matthew J Carpenter, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

February 6, 2015

Study Start

November 1, 2014

Primary Completion

May 1, 2016

Study Completion

July 1, 2017

Last Updated

April 4, 2018

Results First Posted

April 4, 2018

Record last verified: 2016-11

Locations

US(1)