Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II (ASPIRE-II)

University of Oklahoma (OU)

Status: Begins enrollment in 4 months

Conditions: Cigarillo Flavor

Treatments: Other: Smoking outcomes

Study type: Interventional

Funder types: Other

Identifiers

NCT06668350

ACS CHERC

CHERC-24-1160021-01-CHERC (Other Grant/Funding Number)

Details and patient eligibility

About

This multi-method project will recruit young adults who currently use cigarillos and examine the effects of different flavored cigarillo types (concept, characterizing, tobacco) on three measures of tobacco product appeal: subjective effects (e.g., taste, enjoyment, satisfaction, reward), actual smoking behavior (e.g., number of puffs), and tobacco product purchases via a simulated experimental tobacco marketplace.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages18 to 34
• Smoke a little cigar or cigarillo (LCCs) "some days" or "everyday" (verified by brand name of the product);
• Ability to read English at an 8th grade level or higher; and
• No immediate plans to quit using tobacco
• > 1 prior experience, even 1 puff, with a flavored tobacco product
• U.S. Citizen or permanent resident of the United States.

Exclusion criteria

• Current use of nicotine replacement therapy (NRT) or stop smoking medication;
• 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 lab 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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190 participants in 3 patient groups

Concept flavored cigarillo

Experimental group

Description:

Participants will smoke a concept flavored cigarillo in the lab

Treatment:

Other: Smoking outcomes

Characterizing flavored cigarillo

Experimental group

Description:

Participants will smoke a characterizing flavored cigarillo

Treatment:

Other: Smoking outcomes

Tobacco flavored cigarillo

Experimental group

Description:

Participants will smoke a tobacco flavored cigarillo

Treatment:

Other: Smoking outcomes