A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers

RAI Services Company1,950 enrolled

Overview

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end-of-study abstinence of healthy adult consumers of combustible cigarettes when provided an electronic nicotine delivery system over a three-month (ninety-day) ambulatory study period. Potential participants will be recruited and enrolled at 27 sites across the United States. Ipsos will recruit participants in person (e.g., through mall intercepts) at each site or by telephone from existing databases of previous research participants. Based on meeting eligibility requirements, participants will be required to read and sign an Informed Consent Form and to attend a site visit to complete enrollment. At the Enrollment Visit, participants will be randomized to one of the three study arms. All participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their assigned study arm. All participants will attend mandatory follow-up site visits on Day 0, Day 30, Day 60, and Day 90, with the option of changing to a different flavor among the available flavors based upon their assigned study arm, if applicable. In the first four weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits on Day 7, Day 14, and Day 21, with the option of changing flavors among those available in their assigned study arm. All site visits will record the number of study investigational product cartridges dispensed, in addition to all used and unused investigational product cartridges returned. During the three-month ambulatory study period, participants will be free to use the study investigational product and any other tobacco or nicotine products as desired. The electronic nicotine delivery system (Version 2) power unit technology will measure their puffing topography during use (including puff duration and the time interval between puffs). The puffing topography data will be automatically transferred to a secure online database via a Bluetooth transfer application using the provided smartphone. Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on the provided smartphone. Surveys will collect data on: 1. The number of cigarettes smoked the previous day 2. Current flavor use 3. Product liking 4. Number of cigarette quit attempts 5. Use of other tobacco or nicotine products 6. Intent to substitute their usual brand combustible cigarettes for the study investigational product (e.g., gradual, complete, or future intent) 7. Social and environmental factors influencing switching intent At the conclusion of the ambulatory study period, all participants will return to the study sites for a close-out period and will then be discharged from the study.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English 2. Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent 3. All female (assigned at birth) candidate participants who agree during the pre-screener to receive and take a home pregnancy test prior to the SEV, and who affirm at the SEV that they are not pregnant or intending to become pregnant. NOTE: Participants who identify as "intersex" or "unknown" during screening, will be offered the opportunity to receive a pregnancy test if they wish to take one. 4. Currently smoke at least 10 cigarettes on smoking days in the past 30 days 5. Smoke cigarettes regularly for at least 12 months 6. Smoke cigarettes on 15 or more of the past 30 days 7. Smoked at least 100 cigarettes in their lifetime prior to the screening and enrollment visit. 8. Must indicate smoking factory-made filtered menthol and/or non-menthol cigarettes as their primary nicotine product (Occasional use of other tobacco- or nicotine-containing products is acceptable) 9. Indicate a willingness to use ENDS 10. Agree to participate in the study and to abide by the study restrictions and requirements, as described in the informed concent form (ICF) Exclusion Criteria: 1. Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report. 2. Female participants who self-report not using adequate methods to prevent pregnancy 3. Persons with pacemakers or other embedded electronic medical devices fitted 4. Persons who self-report heart disease, high blood pressure, diabetes, cancer, Chronic Obstructive Pulmonary Disease, emphysema, asthma or other lung/breathing conditions, a previous history of heart attack or stroke, or are taking medication for depression. 5. Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including those listed below: 1. Carvone (L-) 2. Benzyl alcohol 6. Participants who have used ENDS, nicotine pouch or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products on 5 or more days in the past 30 days 7. Participants who have used ENDS, nicotine pouch or smokeless tobacco products more than 100 times in their lifetime 8. Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days. 9. Employee of a company that manufactures tobacco or ENDS products 10. Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products 11. Have taken part in a tobacco/nicotine research study in the past 30 days

Locations (27)

CRG Test America-Phoenix

Chandler, Arizona, United States

RECRUITING

C&C-Fort Smith

Fort Smith, Arkansas, United States

RECRUITING

Research America Orlando

Altamonte Springs, Florida, United States

RECRUITING

C&C-Tampa

Clearwater, Florida, United States

RECRUITING

Sago Orlando

Maitland, Florida, United States

RECRUITING

CRG Test America-Pembroke Pines

Miami, Florida, United States

RECRUITING

CRG Test America-Ormond Beach

Ormond Beach, Florida, United States

RECRUITING

C&C-Plantation

Plantation, Florida, United States

RECRUITING

C&C-Sebring

Sebring, Florida, United States

RECRUITING

C&C-Tallahassee

Tallahassee, Florida, United States

RECRUITING

...and 17 more locations

Outcomes

Primary Outcomes

Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period

The odds (i.e., relative probabilities) of participants self-reporting 7-day point prevalence abstinence from combustible cigarette (CC) smoking, as recorded in an electronic diary (eDiary) during the final 7 days of the 13-week study period, comparing Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3.

Time frame: 13-weeks

Secondary Outcomes

Odds of final 7-day abstinence between each of the preferred flavor groups (Study Arms 1 and 2).

Odds of self-reported final 7-day point prevalence abstinence from combustible cigarette smoking between preferred flavor groups (Study Arms 1 and 2), assessed via electronic diary (eDiary)

Time frame: 13-weeks

Odds rate of final 7-day complete switching between each of the preferred flavor groups (Study Arms 1 and 2 only).

Time frame: 13-weeks

Time to first 7-day abstinence by Study Arm.

Time frame: 13-weeks

Time to first 7-day abstinence by preferred flavor group.

Time frame: 13-weeks

Weekly mean percent cigarettes per day reductions from baseline by Study Arm and preferred flavor group.

Time frame: 13-weeks

Odds of 50% average weekly cigarettes per day reduction from baseline to final 7-days of study between Study Arm 1 and Study Arm 3, and between Study Arm 2 and Study Arm 3.

Odds of achieving ≥50% reduction in average self-reported cigarettes per day (CPD) from baseline to final 7 days of the study, based on daily entries in an electronic diary (eDiary), comparing Study Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3

Time frame: 13-weeks

A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers

Overview

Conditions

Interventions

Eligibility

Locations (27)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts