Nicotine Use Disorder
Conditions
Brief summary
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.
Detailed description
This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence. As of October 2020, this protocol was updated in which an additional lab session was added. Participants are to complete 4 lab sessions in which they will use an e-cigarette and complete questionnaires. In each individual lab session, they will sample one of the following four e-liquids: cherry, vanilla, menthol, tobacco. Additionally, participant age range was shifted to 21-50 with the younger condition being 21-34 and older being 35-50 and cigarette requirement was at least 1 cigarette/day at this time to be more representative of current persons who smoke.
Interventions
DRUGNicotine
Nicotine level (6 or 18 mg)
DRUGFlavor
Flavor of e-juice (tobacco, menthol, cherry, vanilla)
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Ages 21-34 years or 35 -50 years * Able to read and write * Smoking \>/= 1 cigarettes or cigars/day * Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes * Not seeking treatment to stop smoking
Exclusion criteria
* Daily use of other drugs including prescribed psychoactive drugs * Any significant current medical or psychiatric condition * Known hypersensitivity to propylene glycol * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Score in Liking/Wanting of E-cigarette | Baseline (+10 minutes) to end of lab session (+40 minutes) | The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \[range -100 to 100\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Nicotine Group (6mg/ml) Participants that were assigned to the low nicotine condition and exposed to tobacco, menthol, cherry, and vanilla. | 62 |
| High Nicotine Group (18mg/ml) Participants that were assigned to the high nicotine condition and exposed to tobacco, menthol, cherry, and vanilla. | 59 |
| Total | 121 |
Baseline characteristics
| Characteristic | Low Nicotine Group (6mg/ml) | Total | High Nicotine Group (18mg/ml) |
|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 8.8 | 35.9 years STANDARD_DEVIATION 8.1 | 35.8 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 13 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 108 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 42 Participants | 79 Participants | 37 Participants |
| Region of Enrollment United States | 62 participants | 121 participants | 59 participants |
| Sex: Female, Male Female | 25 Participants | 46 Participants | 21 Participants |
| Sex: Female, Male Male | 37 Participants | 75 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 52 | 0 / 51 | 0 / 51 | 0 / 59 | 0 / 57 | 0 / 59 | 0 / 56 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 0 / 55 | 0 / 52 | 1 / 51 | 0 / 51 | 1 / 59 | 0 / 57 | 0 / 59 | 0 / 56 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 55 | 0 / 52 | 0 / 51 | 0 / 51 | 0 / 59 | 0 / 57 | 0 / 59 | 0 / 56 | 0 / 8 | 0 / 6 |
Outcome results
Primary
Change Score in Liking/Wanting of E-cigarette
The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale \[range -100 to 100\] with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)
Time frame: Baseline (+10 minutes) to end of lab session (+40 minutes)
Population: The study started in May 2019 and the study was active between May 2019 and October 2020 and 9 participants were enrolled. However, due to study changes communicated previously, analyses only reflect enrolled participants who completed the study following the study protocol change (i.e., addition of a laboratory session in October 2020). Randomized non-starters were excluded from analyses (n=8, 5 low nicotine, 3 high nicotine). Those who completed at least one lab had data included in analyses
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Nicotine, Tobacco | Change Score in Liking/Wanting of E-cigarette | -1.06 units on scale | Standard Error 4.68 |
| Low Nicotine, Menthol | Change Score in Liking/Wanting of E-cigarette | -5.59 units on scale | Standard Error 4.67 |
| Low Nicotine,Cherry | Change Score in Liking/Wanting of E-cigarette | -7.14 units on scale | Standard Error 4.8 |
| High Nicotine, Tobacco | Change Score in Liking/Wanting of E-cigarette | -7.63 units on scale | Standard Error 4.72 |
| High Nicotine, Menthol | Change Score in Liking/Wanting of E-cigarette | 8.41 units on scale | Standard Error 4.73 |
| High Nicotine, Cherry | Change Score in Liking/Wanting of E-cigarette | 0.42 units on scale | Standard Error 4.78 |
| Low Nicotine, Vanilla | Change Score in Liking/Wanting of E-cigarette | 4.77 units on scale | Standard Error 4.65 |
| High Nicotine, Vanilla | Change Score in Liking/Wanting of E-cigarette | 5.48 units on scale | Standard Error 4.74 |