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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-30
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

21-30 years old

Use ONPs daily

Drink alcohol at least three days/week

Read and speak English

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ecological Momentary Assessment

    Other intervention

    Complete EMAs

  • Monitoring

    Other intervention

    Wear alcohol monitoring wristband

  • Nicotine Oral Pouch

    Drug

    Receive ONPs

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Low concentration, smooth-flavoredExperimental treatment 4 interventions
Group B: High concentration, smooth-flavoredExperimental treatment 4 interventions
Group C: Low concentration, spearmint-flavoredExperimental treatment 4 interventions
Group D: High concentration, spearmint-flavoredExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Alcohol consumption

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

Time frame
Four 10-day ONP use periods
2

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.

Time frame
Four 10-day ONP use periods
3

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.

Time frame
Four 10-day ONP use periods

Secondary outcomes

Other outcomes

Sponsors and contacts

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