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

The Ohio State University

Status and phase: Completed; Early Phase 1

Conditions: Tobacco-Related Carcinoma

Treatments: Other: Questionnaire Administration; Drug: Smokeless Tobacco; Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT05730439

NCI-2023-00134 (Registry Identifier)

OSU-22197

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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71 participants in 6 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Procedure: Biospecimen Collection

Drug: Smokeless Tobacco

Other: Questionnaire Administration

Drug: Nicotine Oral Pouch

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

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Procedure: Biospecimen Collection

Drug: Smokeless Tobacco

Other: Questionnaire Administration

Drug: Nicotine Oral Pouch

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

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Procedure: Biospecimen Collection

Drug: Smokeless Tobacco

Other: Questionnaire Administration

Drug: Nicotine Oral Pouch

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

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Procedure: Biospecimen Collection

Drug: Smokeless Tobacco

Other: Questionnaire Administration

Drug: Nicotine Oral Pouch

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

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Procedure: Biospecimen Collection

Drug: Smokeless Tobacco

Other: Questionnaire Administration

Drug: Nicotine Oral Pouch

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

Experimental group

Description:

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

Treatment:

Drug: Nicotine Oral Pouch

Procedure: Biospecimen Collection

Drug: Smokeless Tobacco

Other: Questionnaire Administration

Drug: Nicotine Oral Pouch