Trial Outcomes & Findings for Effects of Random Nicotine Delivery on Smoking Cessation (NCT NCT03674970)
NCT ID: NCT03674970
Last Updated: 2021-01-22
Results Overview
CPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Baseline and 4 weeks after Target Quit Date
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Random Nicotine Delivery
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Random Nicotine Delivery on Smoking Cessation
Baseline characteristics by cohort
| Measure |
Random Nicotine Delivery
n=15 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=15 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Cigarettes Per Day
|
19.6 Cigarettes per day
STANDARD_DEVIATION 7.7 • n=5 Participants
|
18.8 Cigarettes per day
STANDARD_DEVIATION 6.6 • n=7 Participants
|
16.8 Cigarettes per day
STANDARD_DEVIATION 4.5 • n=5 Participants
|
18.4 Cigarettes per day
STANDARD_DEVIATION 6.4 • n=4 Participants
|
|
Fagerstrom Test for Nicotine Dependence Total Score
|
5.0 Scores on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
4.9 Scores on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
4.3 Scores on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
4.7 Scores on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks after Target Quit DateCPD is measured with the use of daily cigarette logs which are completed daily by participants and returned to the study center at each visit. The CPD measure will be the average of the past 7 days.
Outcome measures
| Measure |
Random Nicotine Delivery
n=15 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=15 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Change in Number of Cigarettes Smoked Per Day (CPD)
|
-10.3 cigarettes per day
Standard Deviation 6.1
|
-9.0 cigarettes per day
Standard Deviation 8.0
|
-7.6 cigarettes per day
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks after Target Quit DateMean change in exhaled CO (parts per million \[ppm\])
Outcome measures
| Measure |
Random Nicotine Delivery
n=15 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=15 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Change in Exhaled Carbon Monoxide (CO) Measurement
|
-16 parts per million
Standard Deviation 18.6
|
-5.9 parts per million
Standard Deviation 13.4
|
-10.5 parts per million
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after Target Quit DateThe QSU-Brief, with a possible total score range of 10 to 70, is an instrument used to measure cigarette craving. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving.
Outcome measures
| Measure |
Random Nicotine Delivery
n=15 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=15 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Total Score
|
-.55 QSU Total Score
Standard Deviation 1.46
|
-.55 QSU Total Score
Standard Deviation 1.36
|
-.11 QSU Total Score
Standard Deviation .97
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after Target Quit DateNicotine dependence will be assessed via the FTND, a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence).
Outcome measures
| Measure |
Random Nicotine Delivery
n=15 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=15 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Change in Fagerstrom Test for Nicotine Dependence (FTND) Total Score
|
-1.1 FTND Total Score
Standard Deviation 1.44
|
-.53 FTND Total Score
Standard Deviation .92
|
-.53 FTND Total Score
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 4 weeks after Target Quit DateThe scale is comprised of 21 items. Each item is rated on a scale 1-7, where 1 is equal to not at all and 7 is equal to extremely. The total score is the average score of all 21 items. The total score ranges from 1-7.
Outcome measures
| Measure |
Random Nicotine Delivery
n=13 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=11 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Subjective Ratings Scale for Nicotine Film Use
|
3.32 score on a scale
Standard Deviation .71
|
2.82 score on a scale
Standard Deviation .46
|
2.74 score on a scale
Standard Deviation .57
|
SECONDARY outcome
Timeframe: 4 weeks after Target Quit DateTotal score ranges from 0 - 36 with lower scores indicating lesser side effects.
Outcome measures
| Measure |
Random Nicotine Delivery
n=13 Participants
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=11 Participants
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 Participants
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Side Effects From Nicotine Film Use
|
17.77 score on a scale
Standard Deviation 4.32
|
15.36 score on a scale
Standard Deviation 3.32
|
17.13 score on a scale
Standard Deviation 5.15
|
Adverse Events
Random Nicotine Delivery
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Steady State Nicotine Delivery
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Control
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Random Nicotine Delivery
n=15 participants at risk
One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Steady State Nicotine Delivery
n=15 participants at risk
One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
Placebo Control
n=15 participants at risk
One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.
Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
26.7%
4/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
13.3%
2/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
6.7%
1/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
|
Gastrointestinal disorders
Hiccups
|
13.3%
2/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
33.3%
5/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
0.00%
0/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
|
Gastrointestinal disorders
Vomitting
|
13.3%
2/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
0.00%
0/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
0.00%
0/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
0.00%
0/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
26.7%
4/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
6.7%
1/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
0.00%
0/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
|
Investigations
Other
|
0.00%
0/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
20.0%
3/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
20.0%
3/15 • Adverse event data was collected at each follow-up visit over a period of 7 weeks total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place