Nicotine strength and flavor in oral pouches and alcohol use in young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.