Oral Nicotine Pouches for Nicotine Intake Study
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Neal Benowitz, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for healthy adults who currently smoke cigarettes or use e-cigarettes. Participants should not have any major health problems and must be willing to try different nicotine pouch strengths as well as their usual nicotine product.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares the effects of oral nicotine pouches (with 0 mg, 3 mg, and 6 mg nicotine) to regular smoking or vaping. Each participant tries all products in random order during four separate hospital visits.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will use their own brand of either cigarettes or e-cigarettes (vapes) on one study day (8 hours)
6 mg oral nicotine pouches used on one study day (8 hours)
3 mg oral nicotine pouches used on one study day (8 hours)
placebo (0 mg nicotine pouches) used on one study day (8 hours)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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