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

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.

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)