A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers

Official title

A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Smoking Abstinence With an Electronic Nicotine Delivery System in Primary Combustible Cigarette Smokers

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, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

Detailed description

This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end of study (EOS) smoking abstinence of healthy adult consumers of combustible cigarettes (CC) when provided an electronic nicotine delivery system (ENDS) over a 13-week study period.

Potential participants will be recruited and enrolled at multiple sites across the U.S. They will complete a pre-screening questionnaire to assess their study eligibility approximately 60 days prior to enrollment. Participants who meet pre-screening criteria will provide an informed consent to attend a screening and enrollment visit (SEV), which is a mandatory site visit (MSV) during which participants will be screened, and eligible participants will be randomized to one of the three study arms.

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 Study Arm.

All participants will attend MSV on Days 0, 30, 60, and 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 4-weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits (OSV) on Days 7, 14, and 21, with the option of changing flavors to a different flavor among the available flavors in their assigned Study Arm. During the 13-week study period, participants will be free to use the ENDS and any other tobacco or nicotine products as desired. The ENDS Version 2 Power Unit technology will measure their puffing topography during use (puff duration and inter-puff interval). Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on their own smart phones. Surveys will collect data on the number of CC smoked the previous day, current flavor use, product liking, number of cigarette quit attempts, and any other tobacco or nicotine products used, intent to substitute their UB CC for the Study IP and social/environmental factors influencing switching intent. At the conclusion of the study period, all participants will return to the sites for a close out period and will be discharged from the study. Safety and adverse events/experiences (AEs) will be monitored throughout the study via a safety Hotline.

Interventions

• Other P2613422
  Tobacco Flavor
• Other P2611222
  Menthol Flavor
• Other P2615522
  Non-tobacco, Non-menthol/Mint Flavor
• Other P2615122
  Non-tobacco, Non-menthol/Mint Flavor
• Other P2615422
  Mint Flavor

Primary outcome measures

• Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period [Time frame: 13 Weeks]

Secondary outcome measures (7)

• Proportion of participants who completely switched during the final 7 days in Study Arm 1 vs. Study Arm 3 and Study Arm 2 vs. Study Arm 3. [Time frame: 13 weeks]
• Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2). [Time frame: 13 weeks]
• Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2) [Time frame: 13 weeks]
• Risk ratio of 50% reduction in average weekly CPD from baseline to final 7-days of study between Study Arm 1 and Study Arm 3 and Study Arm 2 and Study Arm 3. [Time frame: 13 weeks]
• Time to first 7-day abstinence by Study Arm and preferred flavor group [Time frame: 13 weeks]
• Weekly mean percent CPD reductions from baseline by Study Arm and preferred flavor group. [Time frame: 13 weeks]
• Safety profile of the study IP [Time frame: 13 weeks]

Eligibility criteria

Inclusion criteria

• Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
• Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent.
• All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
• Currently smoke at least 5 CC on smoking days in the past 30 days.
• Smoke CC on 15 or more of the past 30 days.
• Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
• Indicate a willingness to use ENDS.
• Own and regularly use a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications.
• Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.

Exclusion criteria

• Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
• Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
• Female participants who self-report not using adequate methods to prevent pregnancy.
• Persons with pacemakers or other embedded electronic medical devices fitted.
• Participants who self-report having an unstable heart condition, severe hypertension or diabetes.
• Persons who self-report they are allergic/sensitive to cosmetics or fragrances, or any ingredient listed in commercial e-cigarette products.
• Participants who self-report poor physical or mental health.
• Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, other combustible products and other oral nicotine products (tablets, gums and lozenges) on 5 or more days in the past 30 days.
• 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.
• Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
• Employee of a company that manufactures tobacco or ENDS products.
• Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
• Have taken part in a tobacco/nicotine research study in the past 30 days.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 7 centers

• Sago Orlando — Maitland
• Sago Atlanta — Atlanta
• Sago St. Louis — St Louis
• L&E Raleigh — Raleigh
• Sago Philadelphia — Philadelphia
• Sago Dallas — Dallas
• Sago Houston — Houston

Identifiers

NCT: NCT07598136 · PHI262612

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗