CSD210904: Study to Assess Actual Use of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in Current Adult Smokers

NCT05102786 | Completed

• 1 other identifier: CSD210904
• Study Type: observational
• Target: 1,180
• Locations: 1 country
• Sites: 10

Brief Summary

This is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S. The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21 to 60 years of age, inclusive, who typically smoke on average (≥5 cigarettes/day) on at least 20 out of the past 30 days will use a heated tobacco product comprising a heating device and four non-combusted cigarette variants (HTP Investigational Product \[IP\]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials.

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (3)

• Number and Proportion of Established Users

  Number and proportion of subjects who meet the definition of "established users" of the HTP IP

  6 weeks

• Number and Proportion of Established Users who reduce their CPD consumption

  Number and proportion of subjects among "established users" of the HTP IP who reduce their CPD consumption by at least 50%

  8 weeks

• Descriptive weekly average CPD consumption

  Descriptive weekly average CPD consumption per subject among all subjects who complete the study, including both established and non-established users of the HTP IP

  8 weeks

Interventions

40007388 OTHER

A non-combusted cigarette used with heated tobacco device 20020064

40007385 OTHER

A non-combusted cigarette used with heated tobacco device 20020064

40007387 OTHER

A non-combusted cigarette used with heated tobacco device 20020064

40007386 OTHER

A non-combusted cigarette used with heated tobacco device 20020064

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study sample will comprise generally healthy, U.S. adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on at least 20 of 30 days, who are not currently quitting all Tobacco- and/or Nicotine-containing Product (TNP) use, and who have no intention of quitting all TNP use in the next three months (quitting CC use only is allowable). Once enrolled, subjects confirming an intent to quit all TNP use during the AUP will be discontinued. A recruiting target for younger smokers (21-30 years old) of approximately 15% will be established to ensure that they are sufficiently represented among the enrolled subjects.

You may qualify if:

• Adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
• Must be a current smoker of factory-made filtered menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and typically smoke on at least 20 days out of the past 30 days.
• Smokes, on average, ≥ 5 combustible cigarettes per day (CPD) on days when cigarettes are smoked.
• Must indicate "an intention to use" the HTP IP after a brief review of product information at the Screening and Enrollment Visit (SEV). Subjects will not try the product at the SEV.
• Available and interested in participating in an 8-week study about the HTP IP.
• Able and willing to comply with all study requirements, including questionnaires, the eDiary reporting procedures, and provide valid contact information.
• Able to read, understand, and willing to sign Informed Consent Forms (ICFs) and complete questionnaires written in English.
• Has not participated in any tobacco-, vapor-, or nicotine-related research within 3 months of screening.

You may not qualify if:

• Self-reports as currently quitting or intending to quit within the next 3 months all tobacco or nicotine product use ("currently" is defined as within (≤) 30 days prior to signing ICF#1). Those who intend to quit CC only can be enrolled.
• Female subjects who are currently pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
• Female subjects who self-report they are not using adequate methods to prevent pregnancy.
• Self-reports "poor" physical health (based on the five-category Population Assessment of Tobacco and Health (PATH) questionnaire): "In general, how would you rate your physical health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
• Self-reports "poor" mental health (based on the five-category PATH questionnaire): "In general, how would you rate your mental health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
• Employees of tobacco or vapor companies.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (10)

Schlesinger Atlanta

Atlanta, Georgia, 30328, United States

Location

Schlesinger Chicago

Chicago, Illinois, 60611, United States

Location

Schlesinger Baltimore

Baltimore, Maryland, 21204, United States

Location

Schlesinger Minneapolis

Edina, Minnesota, 55439, United States

Location

Schlesinger Kansas City

Kansas City, Missouri, 64114, United States

Location

Schlesinger St. Louis

St Louis, Missouri, 63131, United States

Location

Schlesinger Charlotte

Charlotte, North Carolina, 28273, United States

Location

Schlesinger Nashville

Nashville, Tennessee, 37203, United States

Location

Schlesinger Dallas

Dallas, Texas, 75254, United States

Location

Schlesinger Houston

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mandara Shetty

  BAT/RAIS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 2, 2021
• Study Start: October 26, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)