NCT06617520

Brief Summary

This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

September 24, 2024

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Subjective response to smoking

    average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7

    Laboratory visits, up to 3 weeks after the baseline

  • Number of cigarillos smoked

    The number of cigarillos smoked during each 7-day take-home period

    Daily smartphone surveys, up to 3 weeks after the baseline

Study Arms (3)

Tobacco flavor cigarillo

EXPERIMENTAL

A participant will use a tobacco flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory

Other: Cigarillo flavor type

Concept flavor cigarillo

EXPERIMENTAL

A participant will use a concept flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory

Other: Cigarillo flavor type

Characterizing flavor

EXPERIMENTAL

A participant will use a characterizing flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory

Other: Cigarillo flavor type

Interventions

Participants will complete a within-subjects design that varies by cigarillo smoked: tobacco flavor, concept flavor, and characterizing flavor

Characterizing flavorConcept flavor cigarilloTobacco flavor cigarillo

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages18 to 34
  • Smoke little cigars/cigarillos (LCCs) "some days" or "everyday"
  • Ability to read English at an 8th grade level or higher
  • No immediate plans to quit using tobacco

You may not qualify if:

  • Current use of nicotine replacement therapy (NRT)
  • Pregnant, planning to become pregnant, or currently breastfeeding
  • Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion Inability to abstain from nicotine/tobacco products for at least 12 hours prior to each of two study sessions
  • Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
  • Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 27, 2024

Study Start

April 15, 2024

Primary Completion

March 15, 2025

Study Completion

May 30, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Sharing may be available at the discretion and with the permission of the university and an approved data use agreement.

Locations