Ohio State University Comprehensive Cancer Center
This clinical trial studies how different ways of using oral nicotine pouches (ONPs) affect nicotine delivery, appeal, and side effects among adult cigarette smokers. ONPs are tobacco-free nicotine products that contain nicotine but no tobacco leaf and are used by placing them between the lip and gum. Because ONPs are not burned and do not contain tobacco leaf, they are being studied as a replacement for tobacco products to lower harmful effects, particularly among adult cigarette smokers. However, previous research on ONP use has often been done via controlled assessments which had users place them in one area of the mouth, which does not reflect how they are used in the real-world. Researchers believe this approach leaves gaps in knowledge on how nicotine is delivered, sensory effects, craving and withdrawal, appeal, and side effects. This trial will have participants use ONPs in different ways, such as placed between the upper lip and gum, placed between the lower lip and gum, and placing them however they would like. Researchers hope that by studying these different use patterns they will understand more about how they affect nicotine delivery, appeal, and side effects among adult cigarette smokers.
PRIMARY OBJECTIVES: I. Quantify the effects of ONP use topography on objective and subjective measures of ONP abuse liability. II. Examine associations between ONP use topography and adverse effects during and after ONP use. SECONDARY OBJECTIVES: I. Describe and code ad libitum ONP use behaviors using video recordings and self-report measures. II. Explore whether specific ad libitum use behaviors, such as movement of the pouch, spitting, squeezing, biting, or placement location, are associated with differences in abuse liability or adverse effects. III. Explore heterogeneity of condition…
Inclusion Criteria: * Read and speak English * At least 21 years old * Established cigarette smoker, defined as having smoked at least 100 lifetime cigarettes and smoking at least 5 cigarettes per day for at least the past year, and have a baseline expired carbon monoxide (eCO) of 7ppm or higher at visit 1 * Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to study visits * Willing to attend all study visits and use study ONPs * Owns a smartphone and is able to receive short message service (SMS) text messages with embed…
Undergo blood sample collection
Complete at-home sampling of ONPs
Use ONP with upper lip and gum placement
Use ONP with lower lip and gum placement
Use ONP with ad libitum use
Ancillary studies