Smoking Clinical Trial
Official title:
A Multi-Site Study to Assess Actual Use of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in Current Adult Smokers
NCT number | NCT05102786 |
Other study ID # | CSD210904 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 26, 2021 |
Est. completion date | March 8, 2022 |
Verified date | June 2022 |
Source | RAI Services Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1180 |
Est. completion date | March 8, 2022 |
Est. primary completion date | March 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID. 2. 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. 3. Smokes, on average, = 5 combustible cigarettes per day (CPD) on days when cigarettes are smoked. 4. 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. 5. Available and interested in participating in an 8-week study about the HTP IP. 6. Able and willing to comply with all study requirements, including questionnaires, the eDiary reporting procedures, and provide valid contact information. 7. Able to read, understand, and willing to sign Informed Consent Forms (ICFs) and complete questionnaires written in English. 8. Has not participated in any tobacco-, vapor-, or nicotine-related research within 3 months of screening. Exclusion Criteria: 1. 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. 2. 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. 3. Female subjects who self-report they are not using adequate methods to prevent pregnancy. 4. 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). 5. 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). 6. Employees of tobacco or vapor companies. |
Country | Name | City | State |
---|---|---|---|
United States | Schlesinger Atlanta | Atlanta | Georgia |
United States | Schlesinger Baltimore | Baltimore | Maryland |
United States | Schlesinger Charlotte | Charlotte | North Carolina |
United States | Schlesinger Chicago | Chicago | Illinois |
United States | Schlesinger Dallas | Dallas | Texas |
United States | Schlesinger Minneapolis | Edina | Minnesota |
United States | Schlesinger Houston | Houston | Texas |
United States | Schlesinger Kansas City | Kansas City | Missouri |
United States | Schlesinger Nashville | Nashville | Tennessee |
United States | Schlesinger St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
RAI Services Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and Proportion of Established Users | Number and proportion of subjects who meet the definition of "established users" of the HTP IP | 6 weeks | |
Primary | 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 | |
Primary | 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 |
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