NCT07095140

Studying the Effects of Nicotine Concentration and Flavor on Alcohol Use in Young Adults

Assessing Co-Use of Oral Nicotine Pouches and Alcohol Among Young Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Ecological Momentary Assessment	Complete EMAs
OTHER	Monitoring	Wear alcohol monitoring wristband
DRUG	Nicotine Oral Pouch	Receive ONPs
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2025-09-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-07-31
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States