Clinical trial NCT05730439: Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
Official title: Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Tobacco-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma nicotine delivery (Aim 1)
timeFrame: From baseline to study completion, assessed up to 2 years
measure: Behavioral intentions (Aim 1)
timeFrame: From baseline to study completion, assessed up to 2 years
measure: Baseline characteristics (Aim 1)
timeFrame: From baseline to study completion, assessed up to 2 years
measure: Smokeless tobacco (SLT) type and behavioral intentions (Aim 2)
timeFrame: From baseline to study completion, assessed up to 2 years
measure: Smokeless tobacco (SLT) dependence effects on NP free-base nicotine (FBN) content on product appeal (Aim 2)
timeFrame: From baseline to study completion, assessed up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brittney L Keller-Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: