Trial Outcomes & Findings for The Moment Study: Mixed Method E-cigarette Study (NCT NCT02261363)
NCT ID: NCT02261363
Last Updated: 2025-05-08
Results Overview
Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
Study Day 7, Week 2
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
Ecig Group 1
On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes (3% nicotine; tobacco or menthol flavor, depending on participants' usual flavor preference) and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished.
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Ecig Group 1
On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes (3% nicotine; tobacco or menthol flavor, depending on participants' usual flavor preference) and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
Baseline Characteristics
The Moment Study: Mixed Method E-cigarette Study
Baseline characteristics by cohort
| Measure |
Ecig Group
n=96 Participants
This is an interventional study with one group.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Menthol preference
Menthol
|
72 participants
n=5 Participants
|
|
Menthol preference
non-menthol
|
24 participants
n=5 Participants
|
|
Educational attainment
high school graduate or lower
|
30 participants
n=5 Participants
|
|
Educational attainment
some college or more
|
66 participants
n=5 Participants
|
|
Fagerstrom test
<=5
|
16 participants
n=5 Participants
|
|
Fagerstrom test
6-7
|
57 participants
n=5 Participants
|
|
Fagerstrom test
8-10
|
23 participants
n=5 Participants
|
|
Age of first cigarette
<=14 years
|
31 participants
n=5 Participants
|
|
Age of first cigarette
15-18 years
|
48 participants
n=5 Participants
|
|
Age of first cigarette
19-24 years
|
12 participants
n=5 Participants
|
|
Age of first cigarette
25-55 years
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 7, Week 2Change in the average number of cigarettes per day comparing average cigarettes per day on study day 6 (last day of cigarette-only use) to average cigarettes per day on study day 7 (first day of e-cigarette and cigarette use).
Outcome measures
| Measure |
Ecig Group 1
n=96 Participants
On study day 6, we provided participants with two NJOY King 5-packs of cigalike e-cigarettes (3% nicotine; tobacco or menthol flavor, depending on participants' usual flavor preference) and asked them to take at least three puffs a day to ensure that they had some exposure to the product in the first week. On day 13, we gave participants two additional NJOY King 5-packs and instructed them to use or not use the e-cigarettes as they wished.
|
|---|---|
|
Cigarette Use
|
-1.82 cigarettes
Interval -2.32 to -1.32
|
Adverse Events
Ecig Group 1
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