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Recruiting NCT07095140

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

No phase Interventional Alcohol-Related Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ecological Momentary Assessment, Monitoring, Nicotine Oral Pouch, Survey Administration.
Who it may be relevant to
Registry conditions: Alcohol-Related Carcinoma. Basic parameters: 21 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07095140 · OSU-24392 · NCI-2025-04731

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗