NCT05960305

Brief Summary

The purpose of this Actual Use Study (AUS) is to investigate how United States (US) adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day on at least 20 of the past 30 days) will use the Cartridge-based ENDS investigational products (Study IP) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environments. Subjects will be able to choose freely among the Study IP available in one of the three study arms to which they are randomly assigned. The three study arms are organized by Study IP flavor categories: tobacco, menthol, and non-tobacco-non-menthol (NTNM). Subjects will self-report their ad libitum use of the Study IP as well as use of Combustible Cigarettes (CC) and any other tobacco- and nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,845

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

July 10, 2023

Last Update Submit

February 22, 2024

Conditions

Smoking, Tobacco

Keywords

Smoking, Tobacco Use, Tobacco Smoking

Outcome Measures

Primary Outcomes (2)

  • Number and proportion of subjects who reduce their cigarettes per day (CPD).

    Number and proportion of subjects who reduce their cigarettes per day (CPD) consumption by at least 50% at Week 6 compared to baseline among all subjects who complete the study.

    6 weeks

  • CPD mean percent reduction

    CPD mean percent reduction at Week 6 compared to baseline among all subjects who complete the study.

    6 weeks

Study Arms (3)

Tobacco Flavor

ACTIVE COMPARATOR

Can choose between 2 different tobacco flavor variants at 2 different nicotine levels (1.5% and 5%)

Other: P1213416Other: P1213422Other: P1213716Other: P1213722

Menthol Flavor

ACTIVE COMPARATOR

Can choose between 2 different menthol flavor variants at 2 different nicotine levels (1.5% and 5%)

Other: P1211216Other: P1211222Other: P1213616Other: P1213622

NTNM Flavor

ACTIVE COMPARATOR

Can choose between 2 different non tobacco/non menthol flavor variants at 2 different nicotine levels (1.5% and 5%)

Other: P1213816Other: P1213822Other: P1211916Other: P1211922

Interventions

P1213416OTHER

Tobacco Flavor

Tobacco Flavor
P1213422OTHER

Tobacco Flavor

Tobacco Flavor
P1213716OTHER

Tobacco Flavor

Tobacco Flavor
P1213722OTHER

Tobacco Flavor

Tobacco Flavor
P1211216OTHER

Menthol Flavor

Menthol Flavor
P1211222OTHER

Menthol Flavor

Menthol Flavor
P1213616OTHER

Menthol Flavor

Menthol Flavor
P1213622OTHER

Menthol Flavor

Menthol Flavor
P1213816OTHER

NTNM Flavor

NTNM Flavor
P1213822OTHER

NTNM Flavor

NTNM Flavor
P1211916OTHER

NTNM Flavor

NTNM Flavor
P1211922OTHER

NTNM Flavor

NTNM Flavor

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Generally healthy adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
  • \. Must be a current smoker of manufactured menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and smoked 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 (in the past 30 days).
  • \. Must indicate "an intention to use" (6 or higher on a 10-point Likert scale) for at least one Study IP flavor per arm across all three study arms after a brief review of the products and related information (i.e. User Guide and Handout MM) at the SEV.
  • \. Has not participated in any tobacco-, ENDS-, or nicotine-related research within 1 month of screening.
  • \. Must sign the Informed Consent Forms (ICFs) and thereby agree to participate in the 8-week study, comply with all study requirements, including eDiary reporting procedures and completion of questionnaires/eDiary in English, and agree that the Study IP received are for their own personal use and will not be shared with others.

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 pre-screening).
  • \. Currently a regular ENDS user (using ENDS \>3 days per week, in the past 30 days), based on self-report.
  • \. Female subjects who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
  • \. Female subjects who state they are not using adequate methods to prevent pregnancy.
  • \. Female subjects (as assigned at birth) who do not have a definitive negative pregnancy test result at SEV.
  • \. Self-reports "poor" physical health
  • \. Self-reports "poor" mental health
  • \. Employees of a company that manufactures tobacco or ENDS products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Sago Phoenix

Phoenix, Arizona, 85016, United States

Location

Non Sago Ft Lauderdale

Fort Lauderdale, Florida, 33309, United States

Location

SAGO Orlando

Orlando, Florida, 32751, United States

Location

Non Sago Tampa

Tampa, Florida, 33634, United States

Location

Sago Atlanta

Atlanta, Georgia, 30328, United States

Location

Sago St. Louis

St Louis, Missouri, 63131, United States

Location

Non-Sago Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Sago Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

Sago Nashville

Nashville, Tennessee, 37203, United States

Location

Sago Dallas

Dallas, Texas, 75254, United States

Location

Sago Houston

Houston, Texas, 77027, United States

Location

Non Sago San Anotonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Tobacco SmokingSmokingTobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kristen Jordan, PhD

    RAIS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 25, 2023

Study Start

September 15, 2023

Primary Completion

January 22, 2024

Study Completion

January 28, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

US(12)