Smoking, Tobacco Use
Conditions
Brief summary
The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.
Interventions
BEHAVIORALLow Power
Participants will receive a low power e-cigarette to use for 3 weeks
BEHAVIORALHigh Power
Participants will receive a high power e-cigarette to use for 3 weeks
BEHAVIORALLow Concentration
Participants will receive a low concentration e-liquid to use for 3 weeks
BEHAVIORALHigh Concentration
Participants will receive a high concentration e-liquid to use for 3 weeks
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include * adults who have been smoking daily * interested in using e-cigarettes * who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily
Exclusion criteria
include * minimal prior e-cigarette use * use of tobacco products other than cigarettes * current use of cessation medications * pregnant, trying to become pregnant, or breastfeeding, * recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension), * household member currently enrolled in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Cigarettes Per Day | Week 3 | Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of E-cigarette Puffing Episodes | Week 3 | Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale |
| Number of Choices to Smoke Cigarette in Lab Setting | Week 3 | Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Concentration / Low Power Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks | 23 |
| Low Concentration / High Power Participant will receive an e-liquid with a low nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
Low Concentration: Participants will receive a low concentration e-liquid to use for 3 weeks | 24 |
| High Concentration / Low Power Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a low power for three weeks.
Low Power: Participants will receive a low power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks | 23 |
| High Concentration / High Power Participant will receive an e-liquid with a high nicotine concentration and an e-cigarette with a high power for three weeks.
High Power: Participants will receive a high power e-cigarette to use for 3 weeks
High Concentration: Participants will receive a high concentration e-liquid to use for 3 weeks | 23 |
| Total | 93 |
Baseline characteristics
| Characteristic | Low Concentration / Low Power | Total | High Concentration / High Power | High Concentration / Low Power | Low Concentration / High Power |
|---|---|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 12 | 49.7 years STANDARD_DEVIATION 12.3 | 49.7 years STANDARD_DEVIATION 11.2 | 51.3 years STANDARD_DEVIATION 13.1 | 48.9 years STANDARD_DEVIATION 13.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 4 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 77 Participants | 17 Participants | 19 Participants | 22 Participants |
| Sex: Female, Male Female | 13 Participants | 48 Participants | 12 Participants | 12 Participants | 11 Participants |
| Sex: Female, Male Male | 10 Participants | 45 Participants | 11 Participants | 11 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 12 / 23 | 13 / 24 | 12 / 23 | 11 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 | 0 / 23 | 0 / 23 |
Outcome results
Primary
Mean Cigarettes Per Day
Participants complete weekly surveys reporting the number of cigarettes smoked each day on a continuous scale
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration / Low Power | Mean Cigarettes Per Day | 13.1 cigarettes per day | Standard Deviation 9.3 |
| Low Concentration / High Power | Mean Cigarettes Per Day | 12.6 cigarettes per day | Standard Deviation 6 |
| High Concentration / Low Power | Mean Cigarettes Per Day | 12.2 cigarettes per day | Standard Deviation 8.8 |
| High Concentration / High Power | Mean Cigarettes Per Day | 13.3 cigarettes per day | Standard Deviation 9.3 |
Secondary
Average Number of E-cigarette Puffing Episodes
Participants complete weekly surveys reporting the number of e-cigarette puffing episodes each day on a continuous scale
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration / Low Power | Average Number of E-cigarette Puffing Episodes | 4.8 cigarettes per day | Standard Deviation 5.4 |
| Low Concentration / High Power | Average Number of E-cigarette Puffing Episodes | 6.5 cigarettes per day | Standard Deviation 10.7 |
| High Concentration / Low Power | Average Number of E-cigarette Puffing Episodes | 5.4 cigarettes per day | Standard Deviation 4.5 |
| High Concentration / High Power | Average Number of E-cigarette Puffing Episodes | 3.0 cigarettes per day | Standard Deviation 4 |
Secondary
Number of Choices to Smoke Cigarette in Lab Setting
Participants complete lab-based choice task at Week 3 visit in which they choose between smoking conventional cigarette and e-cigarette over 10 trials. Outcome is number of times each participant chooses to smoke conventional cigarette.
Time frame: Week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Concentration / Low Power | Number of Choices to Smoke Cigarette in Lab Setting | 1.7 Events | Standard Error 0.42 |
| Low Concentration / High Power | Number of Choices to Smoke Cigarette in Lab Setting | 2.4 Events | Standard Error 0.38 |
| High Concentration / Low Power | Number of Choices to Smoke Cigarette in Lab Setting | 1.8 Events | Standard Error 0.44 |
| High Concentration / High Power | Number of Choices to Smoke Cigarette in Lab Setting | 2.4 Events | Standard Error 0.43 |