Assessing Co-Use of Oral Nicotine Pouches and Alcohol Among Young Adults
Ohio State University Comprehensive Cancer Center
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.
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,…
Eligibility
- Age range
- 21–30 years
- Sex
- All
- 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…
Interventions
- OtherEcological Momentary Assessment
Complete EMAs
- OtherMonitoring
Wear alcohol monitoring wristband
- DrugNicotine Oral Pouch
Receive ONPs
- OtherSurvey Administration
Ancillary studies
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio