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

University of Nevada, Reno

Status: Completed

Conditions: Smoking Behaviors

Treatments: Other: Cigarette trial

Study type: Interventional

Funder types: Other

Identifiers

NCT05468333

5R01DA053619

Details and patient eligibility

About

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).

Enrollment: 184 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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184 participants in 1 patient group

Main arm

Experimental group

Description:

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

Treatment:

Other: Cigarette trial