Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Electronic Cigarette Use

Treatments

Other: Tobacco product administration and assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05971823

HM20025464

2U54DA036105 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users.

The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy (determined by self-report)
at least 18 years old
willing to provide informed consent
able to attend the lab and use designated products according to the study protocol
smoke cigarettes at least 3 days per week, and on those days, at least one cigarette is smoked per day
positive urine cotinine test

Exclusion criteria

Women who are breastfeeding or test positive for pregnancy (by urinalysis) at screening.
Individuals with the following self-reported current, diagnosed medical condition(s) will be excluded automatically: uncontrolled high blood pressure (via self-report or observed at screening; BP must be less than 160/100), heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures.
Individuals with other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor. We ask a variety of questions about participants' medical conditions that are not necessarily exclusionary to be able to consult with the medical monitor about these conditions. Participants with any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations.
Individuals with current, diagnosed, uncontrolled psychiatric conditions will be excluded. A controlled psychiatric illness is defined as one where the individual is taking medication and/or receiving other treatment (e.g., psychotherapy). In addition, individuals who have been to the ER and/or been hospitalized for a psychiatric condition in the past year will be excluded. Individuals with past-month use of cocaine, opioids, benzodiazepines, and methamphetamine or other illegal substances (other than cannabis) will be excluded. Individuals who report using cannabis more than 15 days in the past 30 and/or alcohol more than 25 days in the past 30 days will be excluded.
Participants who choose not to answer questions related to inclusion/exclusion criteria will be excluded.
Participants who indicate their sex assigned at birth is female will be excluded if they are breastfeeding or test positive for pregnancy (by urinalysis) at screening.