Switching to Potential Reduced Exposure Products in Adult Smokers

NCT04250727 | Completed Results DMC FDA Device

• 1 other identifier: 2000023826
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Oral Nicotine Pouch Use; Smoking Behaviors; Harm Reduction; Toxic Effect of Tobacco and Nicotine; Carcinogenesis

Outcome Measures

Primary Outcomes (1)

• Number of Cigarettes Smoked Per Day (Log-transformed)

  The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.

  up to week 4

Secondary Outcomes (4)

• Number of Participants Who Switched From Cigarettes to the ZYN Pouches.

  This will be evaluated at week 4.

• Percentage of Smoke Free Days.

  up to week 4

• Level of Biomarker (NNAL) Among Smokers

  baseline and week 4

• Subjective Effects of Oral Nicotine Pouches

  week 4

Study Arms (2)

3mg Nicotine Concentration

EXPERIMENTAL

15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

Device: ZYN

6mg Nicotine Concentration

EXPERIMENTAL

15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

Device: ZYN

Interventions

ZYN DEVICE

30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

3mg Nicotine Concentration; 6mg Nicotine Concentration

Eligibility Criteria

• Age: 21 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
• History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
• Current uncontrolled medical condition
• 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)
• 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
• Severe lung disease that requires supplemental oxygen
• Uncontrolled asthma (\<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
• Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
• Planning to quit smoking with a set goal or time for quit attempt
• Known hypersensitivity to propylene glycol
• Patients with an FEV1 \< 40%

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

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MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Harm Reduction; Carcinogenesis

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lisa Fucito, PhD: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
• Organization: Yale School of Medicine

lisa.fucito@yale.edu

(203) 688-1878

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 31, 2020
• Study Start: May 1, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: May 1, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)