Cigarillo SmokingNCT06863168
Cigarillo Public Education Messaging for Black Young Adults
A study testing Cigarillo Health Harm and Nicotine Addiction Messaging and Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies in people with Cigarillo Smoking, run by Drexel University at 2 sites in United States.
Trial summary
This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cigarillo Smoking
- What is being tested?
- Cigarillo Health Harm and Nicotine Addiction Messaging and Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 to 30 years of age;
- Self-identify as non-Hispanic Black or African American ethnicity and race, respectively;
- Must be able to communicate, read, and write in the English language;
- Have never used cigarillos fairly regularly based on a valid measure but are deemed susceptible to cigarillo smoking based on a valid 4-item susceptibility measure; OR currently smokes cigarillos some days but not every day (i.e., experimentation)
- And must have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)
Who cannot join
- Persons who are younger than 18 years of age or older than 30 years of age.
- Persons who do not self-identify as a non-Hispanic Black/African American person.
- Persons who are not deemed susceptible based on a valid susceptibility measure (i.e., not susceptible to cigarillo smoking)
- Persons who have fairly regular use of any tobacco product (i.e., persons with a former or current established pattern of any tobacco use including cigarillos, little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)
- Persons who are unable to read, write, and communicate in English language. The informed consent and other materials, including surveys, are only available in the English language for this study. Additionally, trained staff members that will communicate and interact with participants for this study can only speak in English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Lilianna Phan, PhD, MPH, MS, 267-359-6069, lp954@drexel.edu
Lilianna Phan, PhD, MPH, MS
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
267-359-6069
About this study
Official title: Effective Cigarillo Public Education Messaging for Black Young Adults
This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point.
Read the detailed description
This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point. Participants will be recruited online through research panel services. Eligible participants will be those who: 1) are of non-Hispanic Black or African American ethnicity and race, respectively; 2) are between 18 to 30 years of age; 3) have never used cigarillos fairly regularly but are deemed susceptible to cigarillo smoking or currently smokes cigarillos some days but not every day; and 4) have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products). Potential participants will be provided with a brief description of the study and a link to the eligibility screener. Those who are eligible will proceed to the online consent form. Eligible and consenting participants will complete an online assessment of demographic characteristics, tobacco use intentions and behaviors, attitudes, and perceptions (e.g., harm perceptions, outcome expectancies), alcohol use, cannabis use, and life experiences. After completing the baseline assessment, participants will be randomly assigned in approximately equal numbers into one of three study arms: 1) cigarillo harm messaging alone; 2) cigarillo harm messaging contextualized to outcome expectancies; and 3) control messaging arm. Each arm includes 16 messages. Harm messaging includes messages about the risks of cigarillo smoking including long-term health risks, short-term health risks, social health risks, and nicotine addiction. Harm messaging contextualized with outcome expectancies includes messages about the health harm and nicotine addiction risks of cigarillos contextualized to cigarillo smoking sensory experiences, anticipated pleasure, relaxation, and satisfaction from cigarillo smoking, social persona/admiration related to cigarillo smoking, and that cigarillo smoking does not align with personal values and authenticity. Control messaging includes messages about food safety. Participants will be emailed and asked to view four study arm messages (i.e., one message per theme) on four days each week for four weeks. On the 4th day of each week, participants will also complete measures of message responses for the four messages viewed that day. Following the intervention period, message recall, tobacco use intentions and behaviors, attitudes, perceptions (e.g., harm perceptions, outcome expectancies), alcohol use, and cannabis use will be assessed at 1-month and 3-month follow-up.
- Conditions
- Cigarillo Smoking
- Being tested
- Cigarillo Health Harm and Nicotine Addiction Messaging, Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarillo Health Harm and Nicotine Addiction MessagingBehavioural
Participants in the harm messaging arm will receive messages about the 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking.
Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome ExpectanciesBehavioural
Participants in the harm messaging contextualized to outcome expectancies arm will receive messages about the health harm and nicotine addiction risks of cigarillo smoking (i.e., 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking) contextualized to one of the following themes: 1) smoking sensory experience, 2) anticipated pleasure, relaxation, and satisfaction from smoking, 3) social persona/admiration related to smoking, and 4) that smoking does not align with personal values and authenticity.
| Study group | Role | What they receive |
|---|---|---|
| Non-Tobacco Messages | No intervention | Participants in the control arm will receive messages about food safety. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. |
| Cigarillo Harm Messaging | Experimental | Participants in the harm messaging arm will receive messages about the 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. Each week's 4 messages will be randomized and include one message from the four harm themes. Receives: Behavioral: Cigarillo Health Harm and Nicotine Addiction Messaging |
| Cigarillo Harm Messages Contextualized to Outcome Expectancies | Experimental | Participants in the harm messaging contextualized to outcome expectancies arm will receive messages about the health harm and nicotine addiction risks of cigarillo smoking contextualized to one of the following themes: 1) smoking sensory experience, 2) anticipated pleasure, relaxation, and satisfaction from smoking, 3) social persona/admiration related to smoking, and 4) that smoking does not align with personal values and authenticity. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. Each week's 4 messages will be randomized and include one message from the four harm themes. Receives: Behavioral: Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarillo harm perceptions
Cigarillo absolute harm perceptions will be measured using three self-report items. One item assesses perceptions of how harmful cigarillo smoking is (1=not at all harmful to 5=extremely harmful). Another item assesses perceptions of likelihood of addiction (1=not likely to 5=very likely). A multi-item measure will measure the level of agreement (1=strongly disagree to 5=strongly agree) that cigarillo smoking would cause various health harms and nicotine addiction risks.
Measured: 1-month; 3-month
Cigarillo outcome expectancies
Cigarillo outcome expectancies will be measured via level of agreement (1=strongly disagree to 5=strongly agree) with various statements of potential anticipated outcomes from cigarillo smoking.
Measured: 1-month; 3-month
Cigarillo use intentions
Cigarillo use intentions will be measured using self-report items related to cigarillo smoking susceptibility (i.e., Do you think that you will use a cigarillo soon?; Do you think that you will use a cigarillo in the next year?; Do you think that in the future you might experiment with cigarillos?; If one of your best friends were to offer you a cigarillo, would you smoke it?) with response options including "definitely yes"; "probably yes"; "probably not"; and "definitely not". Combination of responses other than "definitely not" to all four items will be considered susceptible to cigarillo smoking. Cigarillo use intentions will also be assessed by one's willingness to smoke cigarillos in various situations with responses ranging from unwilling=0% to extremely willing=100%.
Measured: 1-month; 3-month
Secondary outcomes (1)
Cigarillo use behaviors
Cigarillo use behaviors will be measured by assessing cigarillo smoking initiation (Have you smoked a cigarillo, even one or two puffs?) and use behaviors (e.g., fairly regular use, current use some days or everyday, the last time a cigarillo was smoked, and the number of cigarillos smoked in the past 30 days) from the baseline time-point.
Measured: 1-month; 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start17 Apr 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarillo SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention consists of cigarillo public education messages that will be delivered online for four days each week for four weeks. Messages will communicate the health harm and nicotine addiction risks of cigarillo smoking alone (i.e., long-term health risks, short-term health risks, social health risks, nicotine addiction); or, contextualized to outcome expectancies of cigarillo smoking sensory experience, anticipated pleasure, relaxation, and satisfaction from cigarillo smoking, social persona/admiration related to cigarillo smoking, and that smoking does not align with personal values and authenticity. These intervention messages will be compared to a control messaging arm. Messaging order of the 16 messages per study arm will be randomized.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863168
- Sponsor's protocol ID
- 2307010033
- Other IDs
- R00CA272919
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Cigarillo Public Education Messaging for Black Young Adults
- ClinicalTrials.gov ID
- NCT06863168
- Acronym / sponsor ID
- 2307010033
- Conditions
- Cigarillo Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point.
Detailed description
This is a 3-arm randomized controlled trial to examine the effects of cigarillo public education messages among Black young adults who are at-risk for established cigarillo smoking. The primary outcomes are cigarillo harm perceptions, outcome expectancies, and use intentions at 3-month follow-up. Exploratory outcomes are use behaviors (cigarillo smoking initiation and use behaviors) measured at 3-month follow-up. These outcomes will also be measured at 1-month follow-up time point. Participants will be recruited online through research panel services. Eligible participants will be those who: 1) are of non-Hispanic Black or African American ethnicity and race, respectively; 2) are between 18 to 30 years of age; 3) have never used cigarillos fairly regularly but are deemed susceptible to cigarillo smoking or currently smokes cigarillos some days but not every day; and 4) have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products). Potential participants will be provided with a brief description of the study and a link to the eligibility screener. Those who are eligible will proceed to the online consent form. Eligible and consenting participants will complete an online assessment of demographic characteristics, tobacco use intentions and behaviors, attitudes, and perceptions (e.g., harm perceptions, outcome expectancies), alcohol use, cannabis use, and life experiences. After completing the baseline assessment, participants will be randomly assigned in approximately equal numbers into one of three study arms: 1) cigarillo harm messaging alone; 2) cigarillo harm messaging contextualized to outcome expectancies; and 3) control messaging arm. Each arm includes 16 messages. Harm messaging includes messages about the risks of cigarillo smoking including long-term health risks, short-term health risks, social health risks, and nicotine addiction. Harm messaging contextualized with outcome expectancies includes messages about the health harm and nicotine addiction risks of cigarillos contextualized to cigarillo smoking sensory experiences, anticipated pleasure, relaxation, and satisfaction from cigarillo smoking, social persona/admiration related to cigarillo smoking, and that cigarillo smoking does not align with personal values and authenticity. Control messaging includes messages about food safety. Participants will be emailed and asked to view four study arm messages (i.e., one message per theme) on four days each week for four weeks. On the 4th day of each week, participants will also complete measures of message responses for the four messages viewed that day. Following the intervention period, message recall, tobacco use intentions and behaviors, attitudes, perceptions (e.g., harm perceptions, outcome expectancies), alcohol use, and cannabis use will be assessed at 1-month and 3-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention consists of cigarillo public education messages that will be delivered online for four days each week for four weeks. Messages will communicate the health harm and nicotine addiction risks of cigarillo smoking alone (i.e., long-term health risks, short-term health risks, social health risks, nicotine addiction); or, contextualized to outcome expectancies of cigarillo smoking sensory experience, anticipated pleasure, relaxation, and satisfaction from cigarillo smoking, social persona/admiration related to cigarillo smoking, and that smoking does not align with personal values and authenticity. These intervention messages will be compared to a control messaging arm. Messaging order of the 16 messages per study arm will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Non-Tobacco Messages | No intervention | –Participants in the control arm will receive messages about food safety. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. |
| Cigarillo Harm Messaging | Experimental | Behavioral: Cigarillo Health Harm and Nicotine Addiction MessagingParticipants in the harm messaging arm will receive messages about the 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. Each week's 4 messages will be randomized and include one message from the four harm themes. |
| Cigarillo Harm Messages Contextualized to Outcome Expectancies | Experimental | Behavioral: Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome ExpectanciesParticipants in the harm messaging contextualized to outcome expectancies arm will receive messages about the health harm and nicotine addiction risks of cigarillo smoking contextualized to one of the following themes: 1) smoking sensory experience, 2) anticipated pleasure, relaxation, and satisfaction from smoking, 3) social persona/admiration related to smoking, and 4) that smoking does not align with personal values and authenticity. Four of the 16 total messages will be emailed with a survey link on four days each week for four weeks. Each week's 4 messages will be randomized and include one message from the four harm themes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between 18 to 30 years of age;
- Self-identify as non-Hispanic Black or African American ethnicity and race, respectively;
- Must be able to communicate, read, and write in the English language;
- Have never used cigarillos fairly regularly based on a valid measure but are deemed susceptible to cigarillo smoking based on a valid 4-item susceptibility measure; OR currently smokes cigarillos some days but not every day (i.e., experimentation)
- And must have no history of fairly regular use of any other tobacco products (i.e., little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)
Key exclusion criteria (5 listed)
- Persons who are younger than 18 years of age or older than 30 years of age.
- Persons who do not self-identify as a non-Hispanic Black/African American person.
- Persons who are not deemed susceptible based on a valid susceptibility measure (i.e., not susceptible to cigarillo smoking)
- Persons who have fairly regular use of any tobacco product (i.e., persons with a former or current established pattern of any tobacco use including cigarillos, little cigars, large cigars, cigarettes, hookah tobacco, electronic vaping products, smokeless tobacco, and heated tobacco products)
- Persons who are unable to read, write, and communicate in English language. The informed consent and other materials, including surveys, are only available in the English language for this study. Additionally, trained staff members that will communicate and interact with participants for this study can only speak in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarillo Health Harm and Nicotine Addiction MessagingParticipants in the harm messaging arm will receive messages about the 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking. | Behavioural | Cigarillo Harm Messaging |
| Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome ExpectanciesParticipants in the harm messaging contextualized to outcome expectancies arm will receive messages about the health harm and nicotine addiction risks of cigarillo smoking (i.e., 1) long-term health risks, 2) short-term health risks, 3) social health risks, and 4) nicotine addiction of cigarillo smoking) contextualized to one of the following themes: 1) smoking sensory experience, 2) anticipated pleasure, relaxation, and satisfaction from smoking, 3) social persona/admiration related to smoking, and 4) that smoking does not align with personal values and authenticity. | Behavioural | Cigarillo Harm Messages Contextualized to Outcome Expectancies |
Primary outcome
Cigarillo harm perceptions
Time frame: 1-month; 3-month
Cigarillo absolute harm perceptions will be measured using three self-report items. One item assesses perceptions of how harmful cigarillo smoking is (1=not at all harmful to 5=extremely harmful). Another item assesses perceptions of likelihood of addiction (1=not likely to 5=very likely). A multi-item measure will measure the level of agreement (1=strongly disagree to 5=strongly agree) that cigarillo smoking would cause various health harms and nicotine addiction risks.
Cigarillo outcome expectancies
Time frame: 1-month; 3-month
Cigarillo outcome expectancies will be measured via level of agreement (1=strongly disagree to 5=strongly agree) with various statements of potential anticipated outcomes from cigarillo smoking.
Cigarillo use intentions
Time frame: 1-month; 3-month
Cigarillo use intentions will be measured using self-report items related to cigarillo smoking susceptibility (i.e., Do you think that you will use a cigarillo soon?; Do you think that you will use a cigarillo in the next year?; Do you think that in the future you might experiment with cigarillos?; If one of your best friends were to offer you a cigarillo, would you smoke it?) with response options including "definitely yes"; "probably yes"; "probably not"; and "definitely not". Combination of responses other than "definitely not" to all four items will be considered susceptible to cigarillo smoking. Cigarillo use intentions will also be assessed by one's willingness to smoke cigarillos in various situations with responses ranging from unwilling=0% to extremely willing=100%.
1 secondary outcome
Cigarillo use behaviors
Time frame: 1-month; 3-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarillo Health Harm and Nicotine Addiction Messaging and Cigarillo Health Harm and Nicotine Addiction Messaging Contextualized to Outcome Expectancies in people with Cigarillo Smoking, run by Drexel University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilianna Phan, PhD, MPH, MS (267-359-6069, lp954@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarillo harm perceptions (time frame: 1-month; 3-month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.