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Cigarette Smoking-Related CarcinomaEarly Phase 1NCT05236894

Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

A Early Phase 1 study testing Cigarette Smoking, Nicotine Oral Pouch and Questionnaire Administration in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Cigarette Smoking-Related Carcinoma
What is being tested?
Cigarette Smoking, Nicotine Oral Pouch and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
1 Mar 2022to 18 Apr 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Use tobacco products other than cigarettes >10 days per month.
  • Use NP in the past 3 months.
  • Unstable or significant psychiatric conditions (past and stable conditions will be allowed).
  • Pregnant, planning to become pregnant, or breastfeeding.
  • History of cardiac event or distress within the past 3 months.
  • Currently attempting to quit all tobacco use.
Show all 20Show fewer
  • Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease.
  • Aim 2 Inclusion Criteria:
  • Age 21 years or older.
  • Reside in a Ohio.
  • Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits.
  • Ability to read and speak English.
  • Smoke at least 5 cigarettes per day for the past 30 days.
  • Use tobacco products other than cigarettes >10 days per month.
  • Use NP in the past 3 months.
  • Unstable or significant psychiatric conditions (past and stable conditions will be allowed).
  • Pregnant, planning to become pregnant, or breastfeeding.
  • History of cardiac event or distress within the past 3 months.
  • Currently attempting to quit all tobacco use.
  • Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Examining the Appeal of Nicotine Pouches in Ohio Appalachia

This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Evaluating nicotine pouches abuse liability among smokers in Ohio including the unique demographic of Appalachia may clarify the public health effect of NPs in Appalachian Ohio and across Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities.

Read the detailed description

Aim 1:

PRIMARY OBJECTIVE:

  1. To estimate the abuse liability of nicotine pouches (NPs) with varying nicotine concentrations relative to cigarette smoking.

SECONDARY OBJECTIVE:

  1. To clarify the public health effect of NPs in Appalachian Ohio.

EXPLORATORY OBJECTIVES:

  1. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring nicotine pharmacokinetics.

II. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring subjective effects.

III. To estimate the abuse liability of NPs with varying nicotine concentrations relative to cigarette smoking by measuring intentions to use and switch to NPs.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive lower dose nicotine pouch orally (PO) over 30 minutes at visits 1, 2, and 3.

ARM II: Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

ARM III: Patients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.

Aim 2:

PRIMARY OBJECTIVE:

  1. To understand the pharmacokinetic difference between tobacco-derived and synthetic NPs.

SECONDARY OBJECTIVE:

  1. To clarify the public health effect of NPs on adult smokers

EXPLORATORY OBJECTIVES:

  1. To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring nicotine pharmacokinetics.

II. To understand the differences in abuse liability between tobacco-derived and synthetic NPs by measuring subjective effects.

III. To estimate the abuse liability of tobacco-derived vs. synthetic NPs by measuring intentions to use and switch to NPs.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive a 3mg dose nicotine pouch orally (PO) over 30 minutes at visits 1, 2, and 3.

ARM II: Patients receive a 3mg dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

ARM III: Patients receive a 3mg dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.

Being tested
Cigarette Smoking, Nicotine Oral Pouch, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cigarette SmokingBehavioural

    Smoke preferred brand of cigarette

  • Nicotine Oral PouchDrug

    Also called ZYN

    Given lower dose nicotine pouch

  • Nicotine Oral PouchDrug

    Also called ZYN

    Given higher dose nicotine pouch

  • Questionnaire AdministrationOther

    Ancillary studies

  • Nicotine Oral PouchDrug

    Also called On!

    Given 3mg nicotine pouch (Aim 2)

  • Nicotine Oral PouchDrug

    Also called ZYN

    Given 3mg nicotine pouch (Aim 2)

  • Nicotine Oral PouchDrug

    Also called Fre

    Given 3mg nicotine pouch (Aim 2)

Study groups in NCT05236894
Study groupRoleWhat they receive
Aim 1: Arm I (lower dose nicotine pouch)ExperimentalPatients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
Receives: Drug: Nicotine Oral Pouch; Other: Questionnaire Administration
Aim 1: Arm II (higher dose nicotine pouches)ExperimentalPatients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
Receives: Drug: Nicotine Oral Pouch; Other: Questionnaire Administration
Aim 1: Arm III (cigarette smoking)Active comparatorPatients smoke usual brand of cigarettes, taking one puff every 30 seconds over 5 minutes at visits 1, 2, and 3.
Receives: Behavioral: Cigarette Smoking; Other: Questionnaire Administration
Aim 2: Arm I (3mg NP)ExperimentalPatients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
Receives: Other: Questionnaire Administration; Drug: Nicotine Oral Pouch
Aim 2: Arm II (3mg NP)ExperimentalPatients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
Receives: Other: Questionnaire Administration; Drug: Nicotine Oral Pouch
Aim 2: Arm III (3mg NP)ExperimentalPatients receive nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
Receives: Other: Questionnaire Administration; Drug: Nicotine Oral Pouch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate plasma nicotine concentration at t=30 minutes for each product.

    Measured: Up to 6 months

Secondary outcomes (4)

  1. Aim 1: Public health effect of NPs in Appalachian Ohio - if NPs can be used as a substitute for cigarette smoking

    Data collected will show if NPs are a viable substitute for cigarette smoking.

    Measured: Up to 6 months

  2. Evaluate plasma nicotine concentrations at t=5 through t=90 minutes

    Measured: Up to 6 months

  3. Evaluate withdrawal relief at t=5 through t=90 minutes

    We measure withdrawal relief using the Minnesota Withdrawal Scale (MNWS). We administer this questionnaire at each timepoint along the standardized scale of t=0, t=5, t=15, t=30, t=60 and t=90. The MNWS includes a minimum value of "none" and a maximum value or "severe." The higher scores indicate increased withdrawal symptoms and lower scores indicate lessened or no withdrawal symptoms.

    Measured: Up to 6 months

  4. Evaluate product appeal across all 3 products

    Product appeal will be assessed using several scales, including the Modified E-Cigarette Smoking Questionnaire (mCEQ), the Product Evaluation Scale (PES), the Adapted Drug Effects Liking Scale, and the Study Product Effects Liking Scale which are administered after the final timepoint of each study visit. For both the mCEQ and PES, the minimum scale value is "not at all" and the maximum scale value is "extremely." Higher scores can mean both better or worse depending on the question. Ex: "Was using your smokeless tobacco satisfying?" and "Did using your smokeless tobacco make you nauseous?" are both questions on each scale, so a higher score would vary in meaning based on the question. For the Adapted Drug Effects Liking and Study Product Effects Liking scales, minimum values include "not at all" and maximum value includes "very pleasant." With the exception of one question on the Study Product Effects Liking Scale, a higher score indicates increased enjoyment of the product.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion18 Apr 2023
  4. Study completion18 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236894
Sponsor's protocol ID
OSU-21257
Other IDs
NCI-2021-14062
Status last verified
May 2024
First submitted
13 Jan 2022
Last updated
21 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Keller-Hamilton B, Alalwan MA, Curran H, Hinton A, Long L, Chrzan K, Wagener TL, Atkinson L, Suraapaneni S, Mays D. Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study. Addiction. 2024 Mar;119(3):464-475. doi: 10.1111/add.16355. Epub 2023 Nov 14.

    PubMed 37964431

  • Keller-Hamilton B, Curran H, Alalwan M, Hinton A, Brinkman MC, El-Hellani A, Wagener TL, Chrzan K, Atkinson L, Suraapaneni S, Mays D. Evaluating the Role of Nicotine Stereoisomer on Nicotine Pouch Abuse Liability: A Randomized Crossover Trial. Nicotine Tob Res. 2025 Mar 24;27(4):658-665. doi: 10.1093/ntr/ntae079.

    PubMed 38713545

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cigarette Smoking, Nicotine Oral Pouch and Questionnaire Administration in people with Cigarette Smoking-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 0 inclusion and 20 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: finished, as of the sponsor's last update on 21 May 2024. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate plasma nicotine concentration at t=30 minutes for each product. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236894, which also lists 2 linked publications.

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 21 May 2024.

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