Oral Nicotine Pouches for Smoking Cessation
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Brittney L Keller-Hamilton, PhD, MPH
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adult cigarette smokers who are interested in trying oral nicotine pouches. Participants should not have any major health issues that would prevent them from safely using nicotine products.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Oral Nicotine Pouches
Trial Overview
The study tests how different ways of using oral nicotine pouches—such as placing them between the upper or lower lip and gum, or however participants prefer—affect nicotine delivery, appeal, cravings, and side effects. Surveys and biological samples will be collected.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 6: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study.
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 5: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study.
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 4: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study.
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 3: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study.
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 2: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study.
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 1: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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