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

Conditions

• Alcohol-Related Carcinoma

Eligibility Criteria

Sex

ALL

Age

21 Years - 30 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 3, 2025

Status verified

Nov 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Low concentration, smooth-flavored
  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.
• Experimental: High concentration, smooth-flavored
  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.
• Experimental: Low concentration, spearmint-flavored
  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.
• Experimental: High concentration, spearmint-flavored
  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.

Primary Outcome Measure

Alcohol consumption [ Time Frame: Four 10-day ONP use periods ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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