Trial Outcomes & Findings for Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy (NCT NCT02628964)
NCT ID: NCT02628964
Last Updated: 2020-02-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline up to 3 weeks
Results posted on
2020-02-24
Participant Flow
Participant milestones
| Measure |
4.5% E-cig
e-cigarettes with nicotine cartridges
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
0 mg E-cig
e-cigarettes with placebo cartridges (0mg).
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
Baseline characteristics by cohort
| Measure |
4.5% E-cig
n=50 Participants
e-cigarettes with nicotine cartridges
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
0 mg E-cig
n=49 Participants
e-cigarettes with placebo cartridges (0mg).
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic African American/black
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other non-Hispanic
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic of any race
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
49 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 3 weeksOutcome measures
| Measure |
4.5% E-cig
n=50 Participants
e-cigarettes with nicotine cartridges
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
0 mg E-cig
n=49 Participants
e-cigarettes with placebo cartridges (0mg).
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
|---|---|---|
|
Changes in the Number of Cigarettes Per Day (CPD)
|
8.2 cigarettes per day (CPD)
Standard Deviation 5.1
|
7.3 cigarettes per day (CPD)
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: up to 3 weeksUsing the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater
Outcome measures
| Measure |
4.5% E-cig
n=40 Participants
e-cigarettes with nicotine cartridges
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
0 mg E-cig
n=39 Participants
e-cigarettes with placebo cartridges (0mg).
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
|---|---|---|
|
Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.
|
.7 proportion of participants
|
.49 proportion of participants
|
SECONDARY outcome
Timeframe: 3 weeksPercentage of participants who responded yes to a yes/no question about experiencing any side effects
Outcome measures
| Measure |
4.5% E-cig
n=40 Participants
e-cigarettes with nicotine cartridges
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
0 mg E-cig
n=39 Participants
e-cigarettes with placebo cartridges (0mg).
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
|---|---|---|
|
Percent of Participants in Each Arm Who Reported Side Effects
|
22.5 percentage of participants
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: no data were collected for this Outcome Measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 weeksPercent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks
Outcome measures
| Measure |
4.5% E-cig
n=39 Participants
e-cigarettes with nicotine cartridges
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
0 mg E-cig
n=40 Participants
e-cigarettes with placebo cartridges (0mg).
e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
|
|---|---|---|
|
Percentage Satisfaction Rating for the E-cigarettes
|
65 percentage of participants
|
71.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: no data were collected for this Outcome Measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: no data were collected for this Outcome Measure
No data displayed because Outcome Measure has zero total participants analyzed.
Outcome measures
Outcome data not reported
Adverse Events
4.5% E-cig
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0 mg E-cig
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place