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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04731 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial studies the use of both (co-use) oral nicotine pouches (ONPs) and alcohol among young adults and whether ONP nicotine concentration and flavor affect alcohol use. The co-use of nicotine and alcohol has grown among young adults and the increase in ONP use among young adults may be a contributing factor. ONPs do not contain tobacco leaf and may reduce cancer risk for those who switch from traditional tobacco products (e.g., cigarettes, moist snuff) to ONPs. However, given that alcohol is a cancer-causing agent, using ONPs might increase alcohol use among young adults, which may cause an increase in their risk of cancer. ONPs come in different nicotine concentrations and flavors, with young adults expressing a preference in nicotine concentration or flavor for use while drinking. The different nicotine concentrations and flavors could lead users to drink more or longer. Studying the co-use of ONPs and alcohol among young adults may help researchers understand whether ONP nicotine concentrations and flavors affect alcohol use. This information may be used to help guide future ONP regulations and cancer prevention interventions targeted to young adults.
PRIMARY OBJECTIVES:
I. Evaluate the role of ONP nicotine concentration on alcohol consumption and side effects during a drinking event.
II. Evaluate the role of ONP flavor on alcohol consumption and side effects of co-use during a drinking event.
III. Describe the effects of ONP nicotine concentration and flavors on next-day side effects after drinking events.
OUTLINE: Participants are randomized to a sequence of 4 ONP with different nicotine concentrations and flavors.
Participants receive four different types of ONPs consisting of low nicotine concentration, high nicotine concentration, unflavored, and spearmint on study. Participants then use the ONPs over 10 days in the order of the assigned sequence for a total of four 10-day periods in the absence of unacceptable toxicity. Participants also complete pre-scheduled ecological momentary assessments (EMAs) over 10 minutes twice daily (BID) and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low concentration, smooth-flavored | Experimental | Participant tries low concentration, Smooth-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study. |
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| High concentration, smooth-flavored | Experimental | Participant tries high concentration Smooth-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study. |
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| Low concentration, spearmint-flavored | Experimental | Participant tries low concentration spearmint-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecological Momentary Assessment | Other | Complete EMAs |
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| Measure | Description | Time Frame |
|---|---|---|
| Alcohol consumption | Alcohol consumption will be estimated with transdermal alcohol content (TAC) collected with a wristband worn by the participants. | Four 10-day ONP use periods |
| Alcohol and ONP co-use side effects | The incidence of side effects including nausea, dizziness, and "head buzz" will be evaluated with the EMA surveys administered on the days of alcohol and ONP co-use. | Four 10-day ONP use periods |
| Alcohol and ONP co-use next-day side effects | The incidence of next-day side effects including nausea, fatigue, sleep disruptions, and shakiness will be evaluated with the EMA surveys administered on the morning after a day where alcohol and ONP were co-used. | Four 10-day ONP use periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCCclinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brittney L Keller-Hamilton, PhD, MPH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D000072860 | Ecological Momentary Assessment |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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This is a single blind study, meaning all participants will be blinded to the study product they use during each 10 day sampling period to avoid potential study bias.
| High concentration, spearmint-flavored | Experimental | Participant tries high concentration spearmint-flavored oral nicotine pouches over a 10-day period in the absence of unacceptable toxicity. Participants also complete pre-scheduled EMAs over 10 minutes BID and as needed on the mornings after a drinking event during each 10-day ONP use period. Additionally, participants wear an alcohol monitoring wristband for at least 22 hours per day on study. |
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| Monitoring | Other | Wear alcohol monitoring wristband |
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| Nicotine Oral Pouch | Drug | Receive ONPs |
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| Survey Administration | Other | Ancillary studies |
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