Clinical trial NCT05157048: Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
Official title: Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Behaviors
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Single-session study utilizing a 2 x 2 mixed factorial design
Primary purpose: PREVENTION

Brief summary: This single laboratory session pilot study will examine the acute effects of cigarette filter type and packaging on initial product perceptions, use, and exposure. Forty adult daily smokers will be randomized to smoke two study-supplied commercially-available cigarettes interspersed by 45 minutes, completing pre- and post-cigarette carbon monoxide and questionnaire measures. We will use a 2 x 2 mixed factorial design to manipulate cigarette filter type (within-subject: charcoal vs. non-charcoal) and packaging (between-subject: light vs. dark).

Detailed description: We will recruit 40 adult daily, non-menthol smokers to a single 2-hr laboratory study where they will smoke two study-provided \[commercially available\] cigarettes, each for a 10-min ad lib period, and then complete product perception and use measures. Smoking sessions will be video recorded and scored to capture puffing behavior, and carbon monoxide (CO) assessments will be collected before and after smoking to assess changes in acute smoke exposure. We will use a 2 x 2 mixed factorial design to manipulate the study-provided cigarette's packaging (between subject factor: light colored 'Sky' package vs. black NAS package; both industry-made) and filter type (within-subject factor: charcoal filter vs. non-charcoal filter; cigarettes will appear identical despite differences in filter composition). Primary outcomes will be product perceptions (risk perceptions, subjective ratings), use behaviors (puffing behavior and purchase task), and acute toxicant exposure (changes in CO).

Eligibility criteria: Inclusion Criteria:

* Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months.
* Smokers of primarily non-menthol cigarettes.
* Not currently undergoing smoking cessation treatment or trying to quit.
* Able to communicate fluently in English (speaking, writing, and reading).
* Capable of giving written informed consent.

Exclusion Criteria:

Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study:

Smoking Behavior

1. Use of menthol cigarettes as preferred/regular brand (defined as using \>20% of the time).
2. Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies).
3. Enrollment or plans to enroll in a smoking cessation program in the next month.
4. Provide an initial Carbon Monoxide (CO) reading \< 5 parts per million (ppm).

Alcohol/Drugs

1. History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
2. Current alcohol consumption that exceeds 25 standard drinks/week.

Medical

1. Women who are pregnant, planning a pregnancy, and/or lactating.
2. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the PI and eligibility will be determined on a case-by-case basis.
3. Color blindness.
4. Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.

Psychiatric

As determined by self-report:

1. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
2. Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible.

Other

Additionally, participants may be deemed ineligible for any of the following general reasons at any point throughout the study, as well as during the initial telephone screen, at the discretion of the PI:

* Significant non-compliance with protocol and/or study design.
* Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data.
* Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance.

Primary outcomes:
measure: Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Total Puffing Duration (Video-scored Smoking Behavior Outcome 2)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Correct Beliefs About Reduced Risks
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Perceived Health Risks Summary Score
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Product Harshness (Subjective Rating Subscale 1)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Smoking Satisfaction (Subjective Rating Subscale 2)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Positive Sensory Experience (Subjective Rating Subscale 3)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Cleanliness (Subjective Rating Subscale 4)
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
measure: Carbon Monoxide (CO) Boost
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
Secondary outcomes:
measure: Intensity
timeFrame: Session 1; assessed after smoking each of the two study cigarettes (i.e., after each filter condition)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
state: Pennsylvania
Study officials:
References: