Alcohol-Related CarcinomaNCT07095140
Studying the Effects of Nicotine Concentration and Flavor on Alcohol Use in Young Adults
A study testing Ecological Momentary Assessment, Monitoring and Nicotine Oral Pouch in people with Alcohol-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Carcinoma
- What is being tested?
- Ecological Momentary Assessment, Monitoring and Nicotine Oral Pouch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-30 years old
- Use ONPs daily
- Drink alcohol at least three days/week
- Read and speak English
- Own an iPhone (required for BACtrack Skyn wristband)
- Used 6 mg nicotine concentration ONPs on at least 20 days of past month
Who cannot join
- Use of other tobacco products > 10 days/month
- Unstable or significant medical condition
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- History of cardiac event or distress within the past three months
- Currently pregnant, planning to become pregnant within six months, or breastfeeding (all participants assigned female at birth will take a pregnancy test at each clinic visit before provision of study products; a negative test will be needed to proceed with product sampling)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Brittney L. Keller-Hamilton, PhD, MPH, 614-366-9652, brittney.keller-hamilton@osumc.edu
Brittney L. Keller-Hamilton
About this study
Official title: Assessing Co-Use of Oral Nicotine Pouches and Alcohol Among Young Adults
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Alcohol-Related Carcinoma
- Being tested
- Ecological Momentary Assessment, Monitoring, Nicotine Oral Pouch, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary AssessmentOther
Also called EMA
Complete EMAs
MonitoringOther
Also called monitor
Wear alcohol monitoring wristband
Nicotine Oral PouchDrug
Also called ZYN
Receive ONPs
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ecological Momentary Assessment; Other: Monitoring; Drug: Nicotine Oral Pouch; Other: Survey Administration |
| 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. Receives: Other: Ecological Momentary Assessment; Other: Monitoring; Drug: Nicotine Oral Pouch; Other: Survey Administration |
| 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. Receives: Other: Ecological Momentary Assessment; Other: Monitoring; Drug: Nicotine Oral Pouch; Other: Survey Administration |
| 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. Receives: Other: Ecological Momentary Assessment; Other: Monitoring; Drug: Nicotine Oral Pouch; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Alcohol consumption will be estimated with transdermal alcohol content (TAC) collected with a wristband worn by the participants.
Measured: 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.
Measured: 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.
Measured: Four 10-day ONP use periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start3 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittney Keller-Hamilton, Ohio State University Comprehensive Cancer Center
- Investigators
- Brittney L Keller-Hamilton, PhD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095140
- Sponsor's protocol ID
- OSU-24392
- Other IDs
- NCI-2025-04731
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Co-Use of Oral Nicotine Pouches and Alcohol Among Young Adults
- ClinicalTrials.gov ID
- NCT07095140
- Acronym / sponsor ID
- OSU-24392
- Conditions
- Alcohol-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low concentration, smooth-flavored | Experimental | Other: Ecological Momentary Assessment, Other: Monitoring, Drug: Nicotine Oral Pouch, Other: Survey AdministrationParticipant 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. |
| High concentration, smooth-flavored | Experimental | Other: Ecological Momentary Assessment, Other: Monitoring, Drug: Nicotine Oral Pouch, Other: Survey AdministrationParticipant 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. |
| Low concentration, spearmint-flavored | Experimental | Other: Ecological Momentary Assessment, Other: Monitoring, Drug: Nicotine Oral Pouch, Other: Survey AdministrationParticipant 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. |
| High concentration, spearmint-flavored | Experimental | Other: Ecological Momentary Assessment, Other: Monitoring, Drug: Nicotine Oral Pouch, Other: Survey AdministrationParticipant 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. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 21-30 years old
- Use ONPs daily
- Drink alcohol at least three days/week
- Read and speak English
- Own an iPhone (required for BACtrack Skyn wristband)
Key exclusion criteria (5 listed)
- Use of other tobacco products > 10 days/month
- Unstable or significant medical condition
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- History of cardiac event or distress within the past three months
- Currently pregnant, planning to become pregnant within six months, or breastfeeding (all participants assigned female at birth will take a pregnancy test at each clinic visit before provision of study products; a negative test will be needed to proceed with product sampling)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary AssessmentAlso: EMAComplete EMAs | Other | High concentration, smooth-flavored, High concentration, spearmint-flavored, Low concentration, smooth-flavored, Low concentration, spearmint-flavored |
| MonitoringAlso: monitorWear alcohol monitoring wristband | Other | High concentration, smooth-flavored, High concentration, spearmint-flavored, Low concentration, smooth-flavored, Low concentration, spearmint-flavored |
| Nicotine Oral PouchAlso: ZYNReceive ONPs | Drug | High concentration, smooth-flavored, High concentration, spearmint-flavored, Low concentration, smooth-flavored, Low concentration, spearmint-flavored |
| Survey AdministrationAncillary studies | Other | High concentration, smooth-flavored, High concentration, spearmint-flavored, Low concentration, smooth-flavored, Low concentration, spearmint-flavored |
Primary outcome
Alcohol consumption
Time frame: Four 10-day ONP use periods
Alcohol consumption will be estimated with transdermal alcohol content (TAC) collected with a wristband worn by the participants.
Alcohol and ONP co-use side effects
Time frame: Four 10-day ONP use periods
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.
Alcohol and ONP co-use next-day side effects
Time frame: Four 10-day ONP use periods
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Brittney L Keller-Hamilton, PhD, MPH principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Assessment, Monitoring and Nicotine Oral Pouch in people with Alcohol-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCCclinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: Four 10-day ONP use periods). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.