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

NCT05102786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1180

Last updated 2022-06-24

No results posted yet for this study

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

Interventions

OTHER

40007388

A non-combusted cigarette used with heated tobacco device 20020064

OTHER

40007385

A non-combusted cigarette used with heated tobacco device 20020064

OTHER

40007387

A non-combusted cigarette used with heated tobacco device 20020064

OTHER

40007386

A non-combusted cigarette used with heated tobacco device 20020064

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Mandara Shetty · BAT/RAIS

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2022-03-08
Completion
2022-03-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102786 on ClinicalTrials.gov