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Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia

NCT ID: NCT05730439

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2024-08-05

Brief Summary

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This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.

Detailed Description

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PRIMARY OBJECTIVES:

I. Assess appeal, perceived substitutability, and nicotine delivery of nicotine pouches (NPs) with high versus (vs.) low free-base nicotine (FBN) content among rural and Appalachian moist snuff users.

II. Evaluate whether smokeless tobacco (SLT) dependence modifies effects of NP FBN content on product appeal, perceived substitutability, and nicotine delivery.

OUTLINE: Participants are randomized to 1 of 6 arms.

ARM I: Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine pouch at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo intravenous (IV) line insertion and collection of blood on study.

ARM II: Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine pouch at study visit 2, and ZYN brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM III: Participants receive ZYN brand nicotine pouch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM IV: Participants receive ZYN brand nicotine pouch at study visit 1, Rogue brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM V: Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM VI: Participants receive Rogue brand nicotine pouch at study visit 1, ZYN brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Conditions

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Tobacco-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm I (usual SLT, ZYN NP, Rogue NP)

Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nicotine Oral Pouch

Intervention Type DRUG

Receive ZYN brand NP

Nicotine Oral Pouch

Intervention Type DRUG

Receive Rogue brand NP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smokeless Tobacco

Intervention Type DRUG

Receive usual SLT

Arm II (usual SLT, Rogue NP, ZYN NP)

Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nicotine Oral Pouch

Intervention Type DRUG

Receive ZYN brand NP

Nicotine Oral Pouch

Intervention Type DRUG

Receive Rogue brand NP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smokeless Tobacco

Intervention Type DRUG

Receive usual SLT

Arm III (ZYN NP, usual SLT, Rogue NP)

Participants receive ZYN brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nicotine Oral Pouch

Intervention Type DRUG

Receive ZYN brand NP

Nicotine Oral Pouch

Intervention Type DRUG

Receive Rogue brand NP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smokeless Tobacco

Intervention Type DRUG

Receive usual SLT

Arm IV (ZYN NP, Rogue NP, usual SLT)

Participants receive ZYN brand nicotine patch at study visit 1, Rogue brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nicotine Oral Pouch

Intervention Type DRUG

Receive ZYN brand NP

Nicotine Oral Pouch

Intervention Type DRUG

Receive Rogue brand NP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smokeless Tobacco

Intervention Type DRUG

Receive usual SLT

Arm V (Rogue NP, usual SLT, ZYN NP)

Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nicotine Oral Pouch

Intervention Type DRUG

Receive ZYN brand NP

Nicotine Oral Pouch

Intervention Type DRUG

Receive Rogue brand NP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smokeless Tobacco

Intervention Type DRUG

Receive usual SLT

Arm VI (Rogue NP, ZYN NP, usual SLT)

Participants receive Rogue brand nicotine patch at study visit 1, ZYN brand nicotine patch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Nicotine Oral Pouch

Intervention Type DRUG

Receive ZYN brand NP

Nicotine Oral Pouch

Intervention Type DRUG

Receive Rogue brand NP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smokeless Tobacco

Intervention Type DRUG

Receive usual SLT

Interventions

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Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Nicotine Oral Pouch

Receive ZYN brand NP

Intervention Type DRUG

Nicotine Oral Pouch

Receive Rogue brand NP

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Smokeless Tobacco

Receive usual SLT

Intervention Type DRUG

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection ZYN Rogue Smoking, Tobacco and Cancer - Smokeless Tobacco

Eligibility Criteria

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Inclusion Criteria

* Age 21 years or older
* Reside in an Ohio Appalachian county or surrounding rural area
* 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
* Daily use of smokeless tobacco for the past 3 months

Exclusion Criteria

* Use tobacco products other than smokeless tobacco \> 10 days per month
* Unstable or significant psychiatric conditions for \> 1 year (past and stable conditions will be allowed)
* Pregnant, planning to become pregnant, or breastfeeding
* History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year
* Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months
* Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, throat, tongue, or other oral cancer, lung cancer, or chronic obstructive pulmonary disease
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Brittney Keller-Hamilton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brittney L Keller-Hamilton, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2023-00134

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-22197

Identifier Type: -

Identifier Source: org_study_id