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

The Ohio State University

Status: Enrolling

Conditions: Alcohol-Related Carcinoma

Treatments: Other: Survey Administration; Drug: Nicotine Oral Pouch; Other: Ecological Momentary Assessment; Other: Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07095140

NCI-2025-04731 (Registry Identifier)

OSU-24392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 30 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 4 patient groups

Low concentration, smooth-flavored

Experimental group

Description:

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.

Treatment:

Other: Monitoring

Other: Ecological Momentary Assessment

Drug: Nicotine Oral Pouch

Other: Survey Administration

High concentration, smooth-flavored

Experimental group

Description:

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.

Treatment:

Other: Monitoring

Other: Ecological Momentary Assessment

Drug: Nicotine Oral Pouch

Other: Survey Administration

Low concentration, spearmint-flavored

Experimental group

Description:

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.

Treatment:

Other: Monitoring

Other: Ecological Momentary Assessment

Drug: Nicotine Oral Pouch

Other: Survey Administration

High concentration, spearmint-flavored

Experimental group

Description:

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.

Treatment:

Other: Monitoring

Other: Ecological Momentary Assessment

Drug: Nicotine Oral Pouch

Other: Survey Administration