A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers

Official title

A Multi-Site Two-Arm Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Combustible Cigarette Smokers

Overview

The goal of this study is to evaluate the rate of end of study complete cigarette reduction in health adult consumers of cigarettes when given access to a heated tobacco product (HTP). The primary study objective is to evaluate the impact of access to HTP Device 1 or HTP Device 2 and a single stick variant on the rate of final 7-day abstinence from smoking cigarettes among U.S. adult smokers at the end of a 3-month study period.

Detailed description

This will be a multi-site, open-label, two-arm study to evaluate the rate of end of study complete combustible cigarette (CC) reduction in healthy adult consumers of CC when given access to a heated tobacco product (HTP) device (glo or glo plus), with one of four variants of HTP consumables (also known as "sticks" or "stick variants", under the brand name "virto") over a 3-month (90-day) actual use period (AUP).

Interventions

• Other 31237616
  Tobacco Flavor #1
• Other 31237617
  Tobacco Flavor #2
• Other 31237571
  Menthol #1
• Other 31237581
  Menthol #2

Primary outcome measures

• Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm. [Time frame: 7 days]

Secondary outcome measures (5)

• The number and proportion of participants who completely switch from combustible cigarette smoking to HTP device 1 or HTP device 2 during the entire final 7 days of the 3 month study period in each study arm and by stick variant within the study arm. [Time frame: 7 days]
• The number and proportion of participants who reduce their combustible cigarettes by more than or equal to 50% within their average weekly cigarettes per day from baseline to final 7 days of the study period in each study arm and by stick variant. [Time frame: 3 months]
• The time to first 7-day abstinence of combustible cigarettes by participants in each study arm and by stick variant within each study arm [Time frame: 3 months]
• The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm [Time frame: 3 months]
• The number and type of adverse experiences/events in relation to use of the Study IP in each study arm and by stick variant within each study arm [Time frame: 3 months]

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, verified with government-issued identification.
• All female (assigned at birth) 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. Note: Participants who identify as "intersex" or "unknown" during screening, will be required to take a pregnancy test if they wish to take one.
• Currently smoke at least five combustible cigarettes on smoking days in the past 30 days.
• Smoke combustible cigarettes on 15 or more of the past 30 days.
• Smoked at least 100 factory-made filtered menthol and/or non-menthol combustible cigarettes in their lifetime prior to the Site Enrollment Visit.
• Must indicate a neutral/positive intention to use at least one stick variant at the Site Enrollment Visit.
• Own 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.
• Must try all four stick variants during the 1-week product trial period.
• Must indicate a neutral/positive intention to use at least one stick variant following the product trial period.

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 time of 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.
• Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
• Participants who have used electronic nicotine delivery system (ENDS), nicotine pouches, HTP or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, other combustible tobacco/nicotine 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.
• Employee of a company that manufactures tobacco or HTPs.
• Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or HTPs.
• 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 · 9 centers

• Opinions Brandon — Brandon
• Opinions Coral Springs — Coral Springs
• Opinions Chicago — Aurora
• Opinions Chicago — Gurnee
• Opinions Las Vegas — Las Vegas
• Opinions Las Vegas — Las Vegas
• Opinions Fort Worth — Fort Worth
• Opinions Houston — Houston
• … and 1 more center

Identifiers

NCT: NCT07710820 · PHI252504

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗