Trial Outcomes & Findings for Effects of Flavors on Nicotine Reinforcement in Smokers (NCT NCT03243630)
NCT ID: NCT03243630
Last Updated: 2020-12-03
Results Overview
The (DEQ) Drug Effects Questionnaire has eleven questions with a minimum score of 0 to a maximum score of 100. Peak values from each time points were calculated for the change in the intensity of positive subjective effects as measured with these peak values for like and want more were averaged to obtain a summary score to represent the feel "good drug effects" composite factor. Higher scores for each DEQ represent greater endorsement of that subjective effect (e.g., on the "like drug" scale a response of 90 represents greater liking than a response of 50).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
26 participants
Primary outcome timeframe
up to 3 hours per test session.
Results posted on
2020-12-03
Participant Flow
A total of 26 subjects were eligible for participation with 24 randomized after completion of the adaptation session. Reasons for exclusion after adaptation session included poor venous access (n=1) and a positive drug screen (n=1).
A total of 26 subjects were eligible for participation with 24 randomized after completion of the adaptation session.
Participant milestones
| Measure |
Study Cohort
In each test session, the flavor was randomly assigned and delivered via the e-cigarette. Then, participants were randomly assigned to receive one intravenous delivery of saline, and two intravenous deliveries of nicotine (3.6 mcg/kg and 7 mcg/kg or 0.25 mg/70 kg and 0.5 mg/70kg), one hour apart.
Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)
Green Apple Flavor + IV saline Green Apple Flavor + IV nicotine (0.25mg/70kg) Green Apple Flavor + IV nicotine (0.5mg/70kg)
Menthol plus Green Apple Flavor + IV saline Menthol plus Green Apple Flavor + IV nicotine (0.25mg/70kg) Menthol plus Green Apple Flavor + IV nicotine (0.5mg/70kg)
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
Menthol E-liquid Saline
|
22
|
|
Overall Study
Menthol E-liquid Higher
|
22
|
|
Overall Study
Menthol E-liquid Lower
|
22
|
|
Overall Study
Green Apple E-liquid Saline
|
20
|
|
Overall Study
Green Apple E-liquid Higher
|
20
|
|
Overall Study
Green Apple E-liquid Lower
|
20
|
|
Overall Study
Green Apple and Menthol E-liquid Saline
|
21
|
|
Overall Study
Green Apple and Menthol E-liquid Higher
|
21
|
|
Overall Study
Green Apple and Menthol E-liquid Lower
|
21
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Study Cohort
In each test session, the flavor was randomly assigned and delivered via the e-cigarette. Then, participants were randomly assigned to receive one intravenous delivery of saline, and two intravenous deliveries of nicotine (3.6 mcg/kg and 7 mcg/kg or 0.25 mg/70 kg and 0.5 mg/70kg), one hour apart.
Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)
Green Apple Flavor + IV saline Green Apple Flavor + IV nicotine (0.25mg/70kg) Green Apple Flavor + IV nicotine (0.5mg/70kg)
Menthol plus Green Apple Flavor + IV saline Menthol plus Green Apple Flavor + IV nicotine (0.25mg/70kg) Menthol plus Green Apple Flavor + IV nicotine (0.5mg/70kg)
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Effects of Flavors on Nicotine Reinforcement in Smokers
Baseline characteristics by cohort
| Measure |
Overall Study
n=24 Participants
The baseline characteristics has been provided for the entire study. Test sessions were randomized by arm, each test session was a different arm.
|
|---|---|
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Age, Continuous
|
26.2 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
6 Participants
n=5 Participants
|
|
Fagerstrom Test of Nicotine Dependence
|
3.2 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Average cigarette consumption per day
|
8.3 cigarette
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Years of smoking
|
13.2 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
serum cotinine level
|
194.4 ng/ml
STANDARD_DEVIATION 123.8 • n=5 Participants
|
|
Positive THC at screen
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 hours per test session.Population: Data was analyzed as Intention to Treat
The (DEQ) Drug Effects Questionnaire has eleven questions with a minimum score of 0 to a maximum score of 100. Peak values from each time points were calculated for the change in the intensity of positive subjective effects as measured with these peak values for like and want more were averaged to obtain a summary score to represent the feel "good drug effects" composite factor. Higher scores for each DEQ represent greater endorsement of that subjective effect (e.g., on the "like drug" scale a response of 90 represents greater liking than a response of 50).
Outcome measures
| Measure |
Menthol E-liquid
n=22 Participants
Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)
IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
green apple: green apple will be added to the menthol flavor
green apple and menthol: menthol and green apple will be the active intervention
|
Green Apple E-liquid
n=20 Participants
Green apple + IV saline Green apple + IV nicotine (0.25mg/70kg) Green apple + IV nicotine (0.5mg/70kg)
IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
green apple: green apple will be added to the menthol flavor
green apple and menthol: menthol and green apple will be the active intervention
|
Green Apple and Menthol E-liquid
n=20 Participants
Green apple and menthol + IV saline Green apple and menthol + IV nicotine (0.25mg/70kg) Green apple and menthol + IV nicotine (0.5mg/70kg)
IV nicotine: Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
Menthol flavor: American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
green apple: green apple will be added to the menthol flavor
green apple and menthol: menthol and green apple will be the active intervention
|
|---|---|---|---|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Higher Nicotine : Max_Cool
|
43.18 units on a scale
Standard Deviation 26.49
|
26.22 units on a scale
Standard Deviation 25.83
|
25.20 units on a scale
Standard Deviation 21.38
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Higher Nicotine : Max_Like
|
56.00 units on a scale
Standard Deviation 28.14
|
53.44 units on a scale
Standard Deviation 28.03
|
50.80 units on a scale
Standard Deviation 34.69
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Higher Nicotine : Max_Dislike
|
24.36 units on a scale
Standard Deviation 29.86
|
25.88 units on a scale
Standard Deviation 31.41
|
20.80 units on a scale
Standard Deviation 27.59
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Higher Nicotine : Max_Craving
|
41.27 units on a scale
Standard Deviation 35.29
|
46.00 units on a scale
Standard Deviation 36.57
|
49.90 units on a scale
Standard Deviation 36.90
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Lower Nicotine: Max_Cool
|
33.27 units on a scale
Standard Deviation 26.16
|
17.47 units on a scale
Standard Deviation 22.45
|
25.90 units on a scale
Standard Deviation 26.66
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Lower Nicotine: Max_Like
|
46.09 units on a scale
Standard Deviation 31.02
|
50.11 units on a scale
Standard Deviation 30.44
|
42.90 units on a scale
Standard Deviation 32.40
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Lower Nicotine: Max_Dislike
|
13.63 units on a scale
Standard Deviation 17.48
|
13.36 units on a scale
Standard Deviation 21.65
|
14.50 units on a scale
Standard Deviation 23.45
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Lower Nicotine: Max_Craving
|
48.00 units on a scale
Standard Deviation 35.69
|
53.16 units on a scale
Standard Deviation 37.34
|
49.00 units on a scale
Standard Deviation 37.95
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Saline: Max_Cool
|
31.45 units on a scale
Standard Deviation 21.97
|
15.50 units on a scale
Standard Deviation 20.56
|
24.60 units on a scale
Standard Deviation 22.96
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Saline: Max_Like
|
33.00 units on a scale
Standard Deviation 30.67
|
35.80 units on a scale
Standard Deviation 31.65
|
32.90 units on a scale
Standard Deviation 27.04
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Saline: Max_Dislike
|
8.72 units on a scale
Standard Deviation 12.64
|
15.50 units on a scale
Standard Deviation 23.75
|
14.40 units on a scale
Standard Deviation 23.79
|
|
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
Saline: Max_Craving
|
46.09 units on a scale
Standard Deviation 39.44
|
57.70 units on a scale
Standard Deviation 36.60
|
55.80 units on a scale
Standard Deviation 38.24
|
Adverse Events
Menthol E-liquid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Green Apple E-liquid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Green Apple and Menthol E-liquid
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