Trial Outcomes & Findings for Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers (NCT NCT02648178)

Last Updated: 2019-09-19

Results Overview

Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

12 Weeks

Results posted on

2019-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Ecigarette Use Enrolled participants using the e-cigarette.
Overall Study STARTED	19
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ecigarette Use n=19 Participants Enrolled participants using the e-cigarette.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	19 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	19 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Outcome measures

Outcome measures
Measure	Ecigarette Use n=13 Participants Enrolled participants using the e-cigarette.
Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day	4.37 number of Daily Cigarettes Interval 3.58 to 5.16

PRIMARY outcome

Timeframe: 12 Weeks

Average number of e-cigarettes used per day over the 12 week period

Outcome measures

Outcome measures
Measure	Ecigarette Use n=13 Participants Enrolled participants using the e-cigarette.
Average Number of E-cigarettes Used Per Day	5.04 ecig sessions per day Interval 3.13 to 6.94

Adverse Events

Ecigarette Use

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Ecigarette Use n=19 participants at risk Enrolled participants using the e-cigarette.
General disorders Death	5.3% 1/19 • Number of events 1 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr James Sargent

The Koop Institute at Dartmouth, Geisel School of Medicine

Phone: 603-653-9025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place