The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are: 1. With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping. 2. With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping. Participants will rate ONP use as a satisfactory substitute for cigarette smoking or vaping. 3. Examine the cardiovascular effects (blood pressure and heart rate) of placebo, 3mg and 6mg ONPs, and the participants' usual cigarette or e-cigarette (vape). Participants will: * use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape) * visit the hospital research ward on 4 separate days for 8 hours each day * use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
24
placebo
low strength oral nicotine pouches
high strength oral nicotine pouches
Participants will use their own cigarette or e-cigarette (vape)
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
This will be assessed by comparing ratios of nicotine area under the plasma nicotine concentration time curve.
Time frame: 7 hours post-dose
With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping.
This will be assessed by administering the Modified Cigarette Evaluation Questionnaire (mCEQ) throughout the day. The mCEQ uses three multi-item subscales and two single items: "Smoking Satisfaction" (items 1, 2, and 12); "Psychological Reward" (items 4 through 8); "Aversion" (items 9 and 10); "Enjoyment of Sensations" (item 3); and "Craving Reduction" (item 11). The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. The minimum total score = 7 and maximum = 35 with higher scores indicating greater intensity on that scale.
Time frame: Pre-dose until 7 hours post-dose.
Cardiovascular effects among arms using heart rate as a measure
The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate after the first dose of nicotine over the following 7 hours among dosages.
Time frame: Pre-dose until 7 hours post-dose
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