"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers

NCT ID: NCT05468333

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2024-08-31

Brief Summary

Smokers believe that cigarettes with the "natural" or "organic" descriptors are less harmful than cigarettes without these descriptors, but we do not know if these beliefs are associated with how smokers interpret the experience of smoking a "natural" or "organic" cigarette, nor whether these beliefs are predictive of changes in smoking behavior or biological exposures. The primary goal of this study is to examine the relationship between exposure to "natural" or "organic" descriptors in cigarette advertising and smoking health risk expectancies, subjective effects, topography, and biological exposures. To accomplish this goal, we will enroll 250 adult daily cigarette smokers of Natural American Spirit (NAS) or non-NAS brands (125 in each group) in a within-subjects human laboratory study manipulating four expectancy conditions (own brand comparator, "natural" advertising, "organic" advertising, "conventional" advertising).

Conditions

Smoking Behaviors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Main arm

All participants received the same intervention; however, the order of the intervention was randomized to reduce the risk of order effects.

Group Type: EXPERIMENTAL

Cigarette trial

Intervention Type: OTHER

Participants were told that they were participating in market research for a new tobacco company called "Capital Tobacco." They were told that they were going to try three different cigarettes for the new company -- a conventional cigarette, a natural cigarette, and an organic cigarette -- and provide the research team with their impressions about the advertising and the smoking experience for each product. We also told them were were studying whether smoking these different types of cigarettes changed their exposure to chemicals in cigarette smoke. The intervention consisted of showing participants conventional, natural, and organic versions of a mailer and reading them a brief description of the brand. In reality, participants were smoking the same cigarette 3 times.

Interventions

Cigarette trial

Participants were told that they were participating in market research for a new tobacco company called "Capital Tobacco." They were told that they were going to try three different cigarettes for the new company -- a conventional cigarette, a natural cigarette, and an organic cigarette -- and provide the research team with their impressions about the advertising and the smoking experience for each product. We also told them were were studying whether smoking these different types of cigarettes changed their exposure to chemicals in cigarette smoke. The intervention consisted of showing participants conventional, natural, and organic versions of a mailer and reading them a brief description of the brand. In reality, participants were smoking the same cigarette 3 times.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Daily cigarette smoker of 5+ cigarettes/day for at least the past 6 months and consumed 100+ lifetime cigarettes
• Smoke non-menthol, filtered cigarettes
• Report daily use of any non-Natural American Spirit (NAS) cigarette brand for the last 30 days (for the non-NAS smoker group), or report daily use of NAS cigarettes for at least 30 days (for the NAS smoker group)
• Provide exhaled CO level >= 10 ppm at the Session 1 visit
• Able to communicate fluently in English (speaking, writing, and reading)
• Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in human participant protections

Exclusion Criteria

• Current use of Nat's cigarettes as a preferred brand
• Plan to quit smoking in the next 30 days and not currently undergoing smoking cessation treatment
• Are pregnant, planning a pregnancy, and/or lactating
• Have any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol
• Have had a serious or unstable disease within the past 6 months (e.g. heart disease, cancer, schizophrenia).
• Cannot have ever regularly smoked NAS (for the non-NAS group)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nevada, Reno

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Pearson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Desert Research Institute

Reno, Nevada, United States

University of Nevada, Reno

Reno, Nevada, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01DA053619

Identifier Type: NIH

Identifier Source: org_study_id

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