Nicotine strength and flavor in oral pouches and alcohol use in young adults
Assessing Co-Use of Oral Nicotine Pouches and Alcohol Among Young Adults
This study tests whether different nicotine strengths and flavors in oral nicotine pouches lead 21–30-year-olds to drink more, drink longer, or have different side effects during and after drinking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 30 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07095140 on ClinicalTrials.gov |
What this trial studies
In a randomized crossover design, participants are assigned to use four types of oral nicotine pouches (low nicotine, high nicotine, unflavored, and spearmint) across four 10-day periods. During each period participants complete twice-daily ecological momentary assessments and morning-after reports when they drink, while wearing an alcohol-monitoring wristband for at least 22 hours per day. The trial enrolls daily ONP users aged 21–30 who drink alcohol at least three days per week and uses within-subject comparisons to detect effects of nicotine concentration and flavor on drinking behavior and side effects. Key exclusions include frequent use of other tobacco products, recent cardiac events, pregnancy, and unstable medical or psychiatric conditions.
Who should consider this trial
Good fit: Ideal candidates are 21–30-year-olds who use oral nicotine pouches daily, drink alcohol at least three days per week, have recent experience with 6 mg ONPs, and own an iPhone for study monitoring.
Not a fit: People who do not use ONPs, drink infrequently, are pregnant or breastfeeding, use other tobacco products more than 10 days per month, or have recent cardiac or unstable psychiatric conditions are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could clarify whether ONP nicotine strength or flavor increases alcohol use in young adults and inform product guidance and harm-reduction messaging to reduce cancer risk.
How similar studies have performed: Prior studies linking nicotine from cigarettes or e-cigarettes to increased alcohol consumption support the co-use concept, but experimental data specific to oral nicotine pouches are limited and this approach is relatively novel for pouches.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Brittney L Keller-Hamilton, PhD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCCclinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.