Alcohol-Related Carcinoma
Conditions
Brief summary
This clinical trial studies the use of both (co-use) oral nicotine pouches (ONPs) and alcohol among young adults and whether ONP nicotine concentration and flavor affect alcohol use. The co-use of nicotine and alcohol has grown among young adults and the increase in ONP use among young adults may be a contributing factor. ONPs do not contain tobacco leaf and may reduce cancer risk for those who switch from traditional tobacco products (e.g., cigarettes, moist snuff) to ONPs. However, given that alcohol is a cancer-causing agent, using ONPs might increase alcohol use among young adults, which may cause an increase in their risk of cancer. ONPs come in different nicotine concentrations and flavors, with young adults expressing a preference in nicotine concentration or flavor for use while drinking. The different nicotine concentrations and flavors could lead users to drink more or longer. Studying the co-use of ONPs and alcohol among young adults may help researchers understand whether ONP nicotine concentrations and flavors affect alcohol use. This information may be used to help guide future ONP regulations and cancer prevention interventions targeted to young adults.
Detailed description
PRIMARY OBJECTIVES: I. Evaluate the role of ONP nicotine concentration on alcohol consumption and side effects during a drinking event. II. Evaluate the role of ONP flavor on alcohol consumption and side effects of co-use during a drinking event. III. Describe the effects of ONP nicotine concentration and flavors on next-day side effects after drinking events. OUTLINE: Participants are randomized to a sequence of 4 ONP with different nicotine concentrations and flavors. Participants receive four different types of ONPs consisting of low nicotine concentration, high nicotine concentration, unflavored, and spearmint on study. Participants then use the ONPs over 10 days in the order of the assigned sequence for a total of four 10-day periods in the absence of unacceptable toxicity. Participants also complete pre-scheduled ecological momentary assessments (EMAs) over 10 minutes twice daily (BID) and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study.
Interventions
Complete EMAs
OTHERMonitoring
Wear alcohol monitoring wristband
Receive ONPs
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
This is a single blind study, meaning all participants will be blinded to the study product they use during each 10 day sampling period to avoid potential study bias.
Eligibility
Sex/Gender
ALL
Age
21 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 21-30 years old * Use ONPs daily * Drink alcohol at least three days/week * Read and speak English * Own an iPhone (required for BACtrack Skyn wristband) * Used 6 mg nicotine concentration ONPs on at least 20 days of past month
Exclusion criteria
* Use of other tobacco products \> 10 days/month * Unstable or significant medical condition * Unstable or significant psychiatric conditions (past and stable conditions will be allowed) * History of cardiac event or distress within the past three months * Currently pregnant, planning to become pregnant within six months, or breastfeeding (all participants assigned female at birth will take a pregnancy test at each clinic visit before provision of study products; a negative test will be needed to proceed with product sampling)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol consumption | Four 10-day ONP use periods | Alcohol consumption will be estimated with transdermal alcohol content (TAC) collected with a wristband worn by the participants. |
| Alcohol and ONP co-use side effects | Four 10-day ONP use periods | The incidence of side effects including nausea, dizziness, and head buzz will be evaluated with the EMA surveys administered on the days of alcohol and ONP co-use. |
| Alcohol and ONP co-use next-day side effects | Four 10-day ONP use periods | The incidence of next-day side effects including nausea, fatigue, sleep disruptions, and shakiness will be evaluated with the EMA surveys administered on the morning after a day where alcohol and ONP were co-used. |
Countries
United States
Contacts
Primary ContactThe Ohio State University Comprehensive Cancer Center
Outcome results
None listed