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

Sponsor
RAI Services Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05102786
Collaborator
(none)
1,180
10
4.4
118
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 40007388
  • Other: 40007385
  • Other: 40007387
  • Other: 40007386

Detailed Description

Adult smokers will be recruited, and candidate subjects who meet study inclusion criteria and none of the exclusion criteria will give verbal consent for further screening. Candidate subjects will be scheduled to attend an in-person Site Enrollment Visit. Subjects will self-report their ad libitum use of the HTP IP as well as use of combustible cigarettes (CCs) and any other tobacco- or nicotine-containing products (TNPs) on a daily basis using an electronic diary (eDiary).

During a 1-week Baseline Assessment Period (BAP), enrolled subjects will record all CC and any other TNP use in the eDiary. At the end of the BAP, subjects will return to the study site for Site Visit 1 (SV1). At this visit, subjects will be provided the HTP IP for the first two weeks of the AUP.

During the subsequent 6-week observational AUP, subjects can choose to use the HTP IP (or not). Subjects will be instructed to record all daily TNP and CC use in the eDiary. They will return to the site every two weeks during the AUP for an in-person interview, to complete questionnaires and for product accountability and resupply. As with SV1, at Site Visit 2 and 3, subjects will be able to select their preferred HTP IP variants (if desired) for use during the subsequent 2-week AUP. Point of sale materials will be present during subject interactions at SVs. After Week 6 of the AUP, there will be a final site visit and week-long Close Out Period.

In addition to collecting information on daily ad libitum use of HTP IP, TNP and CC use, the study will assess subjective measures for each HTP IP, including product use/misuse and intent to use again (at close of study). Information on intention to quit CC use will be collected at enrollment and at study conclusion. A passive surveillance mechanism will be used to collect information on adverse health experiences.

Study Design

Study Type:
Observational
Actual Enrollment :
1180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Oct 26, 2021
Actual Primary Completion Date :
Mar 8, 2022
Actual Study Completion Date :
Mar 8, 2022

Outcome Measures

Primary Outcome Measures

  1. Number and Proportion of Established Users [6 weeks]

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

  2. Number and Proportion of Established Users who reduce their CPD consumption [8 weeks]

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

  3. Descriptive weekly average CPD consumption [8 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Schlesinger Atlanta Atlanta Georgia United States 30328
2 Schlesinger Chicago Chicago Illinois United States 60611
3 Schlesinger Baltimore Baltimore Maryland United States 21204
4 Schlesinger Minneapolis Edina Minnesota United States 55439
5 Schlesinger Kansas City Kansas City Missouri United States 64114
6 Schlesinger St. Louis Saint Louis Missouri United States 63131
7 Schlesinger Charlotte Charlotte North Carolina United States 28273
8 Schlesinger Nashville Nashville Tennessee United States 37203
9 Schlesinger Dallas Dallas Texas United States 75254
10 Schlesinger Houston Houston Texas United States 77027

Sponsors and Collaborators

  • RAI Services Company

Investigators

  • Study Director: Mandara Shetty, BAT/RAIS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RAI Services Company
ClinicalTrials.gov Identifier:
NCT05102786
Other Study ID Numbers:
  • CSD210904
First Posted:
Nov 2, 2021
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 24, 2022