Informing Oral Nicotine Pouch Regulations to Promote Public Health

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying oral nicotine pouches (ONPs) to see if they can be a safer alternative to smoking cigarettes or using smokeless tobacco. ONPs contain nicotine but do not have tobacco, and they are believed to be less harmful than traditional tobacco products. The goal of the study is to understand how these pouches can help adult tobacco users switch from higher-risk products to something that might be safer for their health.

To participate in this trial, you need to be at least 21 years old, speak and read English, and be an established smoker or user of moist snuff (a type of smokeless tobacco). You must also be willing to stop using all tobacco and nicotine products for at least 12 hours before visits and attend all study appointments. Participants will receive ONPs to use and will be asked to report their experiences through text messages. It's important to note that the study is not for individuals who are pregnant, planning to get pregnant, or currently trying to quit all tobacco products. Overall, this trial aims to gather important information that could lead to better regulations and safer alternatives for tobacco users.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Read and speak English
• • At least 21 years old
• • Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits
• • Willing to attend all study visits and use study ONPs
• • Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use)
• • Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant
• • Exhaled carbon monoxide (CO) reading \< 10 (Phase 1)
• • CIGARETTE SMOKERS ONLY: Established cigarette smoker (has smoked at least 100 cigarettes, has smoked daily for at least the past 3 months, now smokes at least 5 cigarettes per day)
• • ST USERS ONLY: Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans/week (as in Pickworth et al., 2014)
• Exclusion Criteria:
• • Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
• • History of cardiac event or distress within the past 3 months
• • Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit \[acute use of usual product and study ONPs\] and Phase 2 study visit 1 \[distribution of study ONPs for outpatient ad libitum use\])
• • Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months
• • Oral or systemic health issues that affect oral microbiome or epithelium, including having fewer than 21 teeth, diabetes mellitus, or autoimmune disease (e.g., rheumatoid arthritis, lupus)
• • CIGARETTE SMOKERS ONLY: Use of non-cigarette tobacco products ≥ 10 of the past 30 days
• • CIGARETTE SMOKERS ONLY: Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease
• • CIGARETTE SMOKERS ONLY: Roll-your-own cigarette smokers
• • ST USERS ONLY: Use of non-moist-snuff tobacco products ≥ 10 of the past 30 days