An interventional study of Ecological Momentary Assessment and Monitoring in Alcohol-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant tries low concentration, Smooth-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes 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.
Other: Ecological Momentary Assessment · Other: Monitoring · Drug: Nicotine Oral Pouch · Other: Survey Administration
Participant tries high concentration Smooth-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes 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.
Other: Ecological Momentary Assessment · Other: Monitoring · Drug: Nicotine Oral Pouch · Other: Survey Administration
Participant tries low concentration spearmint-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes 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.
Other: Ecological Momentary Assessment · Other: Monitoring · Drug: Nicotine Oral Pouch · Other: Survey Administration
Participant tries high concentration spearmint-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes 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.
Other: Ecological Momentary Assessment · Other: Monitoring · Drug: Nicotine Oral Pouch · Other: Survey Administration
Complete EMAs
Also known as: EMA
Wear alcohol monitoring wristband
Also known as: monitor
Receive ONPs
Also known as: ZYN
Ancillary studies
Alcohol consumption
Alcohol consumption will be estimated with transdermal alcohol content (TAC) collected with a wristband worn by the participants.
Time frame: Four 10-day ONP use periods
Alcohol and ONP co-use side effects
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.
Time frame: Four 10-day ONP use periods
Alcohol and ONP co-use next-day side effects
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.
Time frame: Four 10-day ONP use periods
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Ohio State University Comprehensive Cancer Center