Clinical trial NCT04250727: Switching to Potential Reduced Exposure Products in Adult Smokers
Official title: Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Oral Nicotine Pouch Use
Smoking Behaviors
Harm Reduction
Toxic Effect of Tobacco and Nicotine
Carcinogenesis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.
Primary purpose: OTHER

Brief summary: This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.


Eligibility criteria: Inclusion Criteria:

1. 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
2. English literate
3. Smoke at least 1 cigarette per day
4. Expired breath carbon monoxide level ≥ 6ppm at baseline
5. Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month
6. Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).

Exclusion Criteria:

1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
3. Current uncontrolled medical condition
4. Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)
5. Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study
6. Severe lung disease that requires supplemental oxygen
7. Uncontrolled asthma (\<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
8. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
9. Planning to quit smoking with a set goal or time for quit attempt
10. Known hypersensitivity to propylene glycol
11. Patients with an FEV1 \< 40%

Primary outcomes:
measure: Number of Cigarettes Smoked Per Day (Log-transformed)
timeFrame: up to week 4
Secondary outcomes:
measure: Number of Participants Who Switched From Cigarettes to the ZYN Pouches.
timeFrame: This will be evaluated at week 4.
measure: Percentage of Smoke Free Days.
timeFrame: up to week 4
measure: Level of Biomarker (NNAL) Among Smokers
timeFrame: baseline and week 4
measure: Subjective Effects of Oral Nicotine Pouches
timeFrame: week 4
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
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