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

NCT07095140 | Recruiting

• 2 other identifiers: OSU-24392NCI-2025-04731
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• Alcohol consumption

  Alcohol consumption will be estimated with transdermal alcohol content (TAC) collected with a wristband worn by the participants.

  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.

  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.

  Four 10-day ONP use periods

Study Arms (4)

Low concentration, smooth-flavored

EXPERIMENTAL

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

High concentration, smooth-flavored

EXPERIMENTAL

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

Low concentration, spearmint-flavored

EXPERIMENTAL

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

High concentration, spearmint-flavored

EXPERIMENTAL

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

Interventions

Ecological Momentary Assessment OTHER

Complete EMAs

Also known as: EMA

High concentration, smooth-flavored; High concentration, spearmint-flavored; Low concentration, smooth-flavored; Low concentration, spearmint-flavored

Monitoring OTHER

Wear alcohol monitoring wristband

Also known as: monitor

High concentration, smooth-flavored; High concentration, spearmint-flavored; Low concentration, smooth-flavored; Low concentration, spearmint-flavored

Nicotine Oral Pouch DRUG

Receive ONPs

Also known as: ZYN

High concentration, smooth-flavored; High concentration, spearmint-flavored; Low concentration, smooth-flavored; Low concentration, spearmint-flavored

Survey Administration OTHER

Ancillary studies

High concentration, smooth-flavored; High concentration, spearmint-flavored; Low concentration, smooth-flavored; Low concentration, spearmint-flavored

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Ecological Momentary Assessment

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Brittney L Keller-Hamilton, PhD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCCclinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)