Tobacco Use
Conditions
Brief summary
The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.
Interventions
OTHERoral nicotine pouch - 2 mg
On brand oral nicotine pouch with 2 mg of protonated nicotine in original flavor
OTHERoral nicotine pouch - 4 mg
On brand oral nicotine pouch with 4 mg of protonated nicotine in original flavor
OTHERoral nicotine pouch - 8 mg
On brand oral nicotine pouch with 8 mg of protonated nicotine in original flavor
OTHERSmokeless tobacco
Participant's typical brand of smokeless tobacco
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy (determined by self-report) * Between the ages of 18-55 * Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required * Agree to use designated products according to study protocol * Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use
Exclusion criteria
* The following self-reported current, diagnosed medical condition(s): 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 * Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations * Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use * Not providing answers to questions related to inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma nicotine concentration | Baseline to the end of the session, approximately 4 hours | Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change physical sensations | Baseline to the end of the session, approximately 4 hours | The Direct Effects of Nicotine Questionnaire (DEN) is used to assess the extent to which product use affects participants physically. It consists of 10 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely. |
| Change in sensations and emotions | Baseline to the end of the session, approximately 4 hours | The Direct Effects of Smokeless Tobacco (DESLT) Questionnaire is used to assess sensations and emotions associated with smokeless tobacco use. It consists of 12 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely. |
| Change emotions and urges | Baseline to the end of the session, approximately 4 hours | The Hughes-Hatsukami Questionnaire (HH) is used to assess the extent to which product use affects a variety of emotions and urges. It consists of 11 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely. |
Countries
United States
Outcome results
None listed