Tobacco Dependence
Conditions
Keywords
Tobacco, Nicotine, Smoking, Addiction
Brief summary
The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.
Detailed description
For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. Laboratory measures of ENDS reinforcement, subjective ENDS ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fMRI) will be collected at baseline and after ten days of ENDS use.
Interventions
OTHERFlavor
E-liquid flavor chemicals
Sponsors
Milton S. Hershey Medical Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 21 to 60 years old 2. Regular users of inhaled tobacco products (≥5 days out of the last 28) 3. Not planning to quit tobacco use within next month 4. Able to read and write in English
Exclusion criteria
1. Major neurological conditions or brain trauma 2. Current substance use impairing participation 3. Unstable or significant medical conditions (e.g., COPD, coronary heart disease) 4. Current use of smoking cessation medication (e.g., varenicline, patch) 5. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months 6. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin 7. Unable to use study provided ENDS ad-libitum for at least 3 hours per day 8. Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen MRI-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Reward Reactivity | Pre to post-intervention (approximately 10 days) | Brain reward reactivity will be calculated as the difference in the percent of BOLD signal calculated by subtracting the absolute percentage at the post-scan from baseline in a pre-defined ventral tegmental area (VTA) region of interest during electronic nicotine delivery system (ENDS) inhalation. |
| Absolute Reinforcement | Pre to post-intervention (approximately 10 days) | Absolute reinforcement will be calculated as the mean difference in puffs per day calculated as the average puffs per day during last four days minus the first four days of the 10-day use period. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 11.01 |
| Current Cigarette Use | 7 Participants |
| Current E-cigarette Use | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 36 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 1 / 19 | 2 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 |
Outcome results
None listed