Clinical trial · Interventional
Studying the Effects of Nicotine Concentration and Flavor on Alcohol Use in Young Adults
Assessing Co-Use of Oral Nicotine Pouches and Alcohol Among Young Adults
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alcohol-Related Carcinoma | Alcohol-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ecological Momentary Assessment | Other | — | UNRESOLVED |
| Monitoring | Other | — | UNRESOLVED |
| Nicotine Oral Pouch | Drug | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Low concentration, smooth-flavored
- 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.
- interventionNames
- Other: Ecological Momentary Assessment
- Other: Monitoring
- Drug: Nicotine Oral Pouch
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- High concentration, smooth-flavored
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available