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

November 21, 2025 updated by: Brittney Keller-Hamilton, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Brittney L. Keller-Hamilton
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Survey Administration
Ancillary studies
Other: Ecological Momentary Assessment
Complete EMAs
Other Names:
  • EMA
Other: Monitoring
Wear alcohol monitoring wristband
Other Names:
  • monitor
Drug: Nicotine Oral Pouch
Receive ONPs
Other Names:
  • ZYN
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.
Other: Survey Administration
Ancillary studies
Other: Ecological Momentary Assessment
Complete EMAs
Other Names:
  • EMA
Other: Monitoring
Wear alcohol monitoring wristband
Other Names:
  • monitor
Drug: Nicotine Oral Pouch
Receive ONPs
Other Names:
  • ZYN
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.
Other: Survey Administration
Ancillary studies
Other: Ecological Momentary Assessment
Complete EMAs
Other Names:
  • EMA
Other: Monitoring
Wear alcohol monitoring wristband
Other Names:
  • monitor
Drug: Nicotine Oral Pouch
Receive ONPs
Other Names:
  • ZYN
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.
Other: Survey Administration
Ancillary studies
Other: Ecological Momentary Assessment
Complete EMAs
Other Names:
  • EMA
Other: Monitoring
Wear alcohol monitoring wristband
Other Names:
  • monitor
Drug: Nicotine Oral Pouch
Receive ONPs
Other Names:
  • ZYN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol consumption
Time Frame: Four 10-day ONP use periods
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
Time Frame: Four 10-day ONP use periods
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
Time Frame: Four 10-day ONP use periods
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Brittney L Keller-Hamilton, PhD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 24, 2025

First Submitted That Met QC Criteria

July 24, 2025

First Posted (Actual)

July 31, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-24392
  • NCI-2025-04731 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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