Recruiting

ONPs & Alcohol

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07095140

Conditions

Alcohol-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21 - 30

Healthy Volunteers: Accepted

Interventions

Ecological Momentary Assessment

Monitoring

Nicotine Oral Pouch

Survey Administration

Study Details

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

Study ID

NCT07095140

Start date

Sep 3, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 30

Healthy Volunteers: Accepted

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 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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Ecological Momentary Assessment

Complete EMAs

Monitoring

Wear alcohol monitoring wristband

Nicotine Oral Pouch

Receive ONPs

Survey Administration

Ancillary studies

Primary outcome measure

  • Alcohol consumption [ Time Frame: Four 10-day ONP use periods ]
  • Alcohol and ONP co-use side effects [ Time Frame: Four 10-day ONP use periods ]
  • Alcohol and ONP co-use next-day side effects [ Time Frame: Four 10-day ONP use periods ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCCclinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Brittney L. Keller-Hamilton, PhD, MPH

614-366-9652brittney.keller-hamilton@osumc.edu

Principal Investigator:

Brittney L. Keller-Hamilton

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2025-11-26.