## Protocol Section
### Identification Module
**NCT ID:** NCT06413797

**Brief Title:** Little Cigar and Cigarillo Warnings for Youth

**Official Title:** Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use

#### Organization Study ID Info
**ID:** 23-2455
#### Organization
**Class:** OTHER
**Full Name:** UNC Lineberger Comprehensive Cancer Center
#### Secondary ID Infos
**ID:** 5R01CA260822-03
**Link:** https://reporter.nih.gov/quickSearch/5R01CA260822-03
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

**Class:** FED

**Name:** Food and Drug Administration (FDA)

#### Lead Sponsor

**Class:** OTHER

**Name:** UNC Lineberger Comprehensive Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.

**Detailed Description:** Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.

Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.

### Conditions Module

**Conditions:**

- Little Cigars and Cigarillos (LCC) Using

**Keywords:**

- cigarette warnings

- youth

- smoke cigars

- nicotine addiction

- cancer prevention

- Black or African American youth

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** At the beginning of the baseline survey (day 1), participants will first consent to participate in the study and then complete a questionnaire about their LCC use and susceptibility, exposure to cigar advertising and warnings, and demographic characteristics, in addition to other measures. At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study conditions.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 2100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will receive messages including FDA-proposed LCC warnings and Images in 30% size. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.

**Intervention Names:**

- Behavioral: Survey

- Behavioral: FDA-proposed Text messages

- Behavioral: Images

**Label:** Text Image

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects will receive text messages including FDA-proposed LCC warnings. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.

**Intervention Names:**

- Behavioral: Survey

- Behavioral: FDA-proposed Text messages

**Label:** Text-only

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.

**Intervention Names:**

- Behavioral: Survey

- Behavioral: Surgeon General Text messages

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- Text Image

- Text-only

**Description:** For six subsequent days (days 2-7) participants will be contacted and asked to complete a daily survey.

**Name:** Survey

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Text Image

- Text-only

**Description:** Participants will receive messages including FDA-proposed LCC warnings.

**Name:** FDA-proposed Text messages

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Text Image

**Description:** Participants will receive messages including images in 30% size.

**Name:** Images

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- Control

**Description:** Participants will receive messages including Surgeon General Text-only Warnings.

**Name:** Surgeon General Text messages

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.

**Measure:** Willingness to use little cigar cigarillos (LCCs)

**Time Frame:** Day 8

#### Secondary Outcomes

**Description:** Past 7 days little cigar use will be measured with separate items for cigarillo and little cigar use by the survey.

**Measure:** Past 7 days little cigar use

**Time Frame:** Day 8

**Description:** Past 7 days cigarillos use will be measured with separate items for cigarillo and little cigar use by survey.

**Measure:** Past 7 days cigarillos use

**Time Frame:** Day 8

**Description:** little cigar cigarillo (LCC) susceptibility will be measured with 3 items by survey.

**Measure:** little cigar cigarillos (LCCs) susceptibility

**Time Frame:** Day 8

**Description:** Cognitive elaboration about dangers will be measured by the survey.

**Measure:** Cognitive elaboration about dangers

**Time Frame:** Days 1,2,3,4,5,6,7,8

**Description:** Cognitive elaboration about dangers will be measured by the survey.

**Measure:** Cognitive elaboration about risk

**Time Frame:** Day 8

**Description:** Cigar appeal will be measured by the survey.

**Measure:** Cigar appeal

**Time Frame:** Days 1,2,3,4,5,6,7,8

**Description:** Warning relevance will be measured by the survey.

**Measure:** Warning relevance

**Time Frame:** Days 1,2,3,4,5,6,7,8

**Description:** Warning negative affect/worry will be measured by the survey.

**Measure:** Warning negative affect/worry

**Time Frame:** Days 1,2,3,4,5,6,7,8

**Description:** Past 7 day little cigar cigarillos (LCCs) use will be measured by the survey.

**Measure:** Past 7 day little cigar cigarillos (LCCs) use

**Time Frame:** Day 8

**Description:** Knowledge of LCC harms will be measured by 13 items the survey.

**Measure:** Knowledge of little cigar cigarillo (LCC) harms

**Time Frame:** Day 8

**Description:** Beliefs about little cigar cigarillo (LCC) harms will be measured with 10 items by survey.

**Measure:** Beliefs about little cigar cigarillo (LCC) harms

**Time Frame:** Day 8

**Description:** LCC risk perceptions

**Measure:** Little cigar cigarillo (LCC) risk perceptions

**Time Frame:** Day 8

**Description:** Reactance to warnings will be measured by survey.

**Measure:** Reactance to warnings

**Time Frame:** Day 8

**Description:** Conversations about cigar health risks will be measured by survey.

**Measure:** Conversations about cigar health risks

**Time Frame:** Day 8

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Agree to provide their honest answers to the survey questionnaire.
* Susceptible to using little cigars and cigarillos (LCC) or have ever used little cigars and/or cigarillos, or currently use little cigars and/or cigarillos in the past 30 days.
* Age 15 - 20 years old
* Currently living in US or US territory

Exclusion Criteria:

* Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
* Not able to answer a simple, random math question.

**Healthy Volunteers:** True

**Maximum Age:** 20 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jkristen@email.unc.edu

**Name:** Kristen Jarman

**Phone:** 919-445-4208

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chapel Hill

**Contacts:**

***Contact 1:***

- **Email:** jkristen@email.unc.edu

- **Name:** Kristen Jarman

- **Phone:** 919-445-4208

- **Role:** CONTACT

**Country:** United States

**Facility:** Lineberger Comprehensive Cancer Center at University of North Carolina

**State:** North Carolina

**Zip:** 27514

#### Overall Officials

**Official 1:**

**Affiliation:** UNC Lineberger Comprehensive Cancer Center

**Name:** Leah Ranney, PhD, MA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Clinical trials at UNC Lineberger

**URL:** http://unclineberger.org/patientcare/clinical-trials/clinical-trials

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19100

- Name: Behavior, Addictive

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
