N/A
N=40
Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure
Smoking Behaviors
Bottom Line
View on ClinicalTrials.gov: NCT05157048 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Nov 2024
Primary outcome: Primary: Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1) — 15.8; 16.7; 19.1; 19.6 puffs
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Charcoal-filtered cigarette (Other); Non-charcoal filtered cigarette (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Puffs Taken (Video-scored Smoking Behavior Outcome 1) |
15.8; 16.7; 19.1; 19.6 | — |
| PRIMARY Total Puffing Duration (Video-scored Smoking Behavior Outcome 2) |
30.4; 32.6; 41.4; 41.2 | — |
| PRIMARY Total Interpuff Interval (Video-scored Smoking Behavior Outcome 3) |
257.7; 290.4; 267.9; 275.0 | — |
| PRIMARY Correct Beliefs About Reduced Risks |
3.8; 3.8; 2.9; 3.2 | — |
| PRIMARY Perceived Health Risks Summary Score |
5.6; 5.4; 5.3; 5.3 | — |
| PRIMARY Product Harshness (Subjective Rating Subscale 1) |
42.1; 42.6; 24.7; 26.2 | — |
| PRIMARY Smoking Satisfaction (Subjective Rating Subscale 2) |
65.8; 55.9; 43.0; 36.2 | — |
| PRIMARY Positive Sensory Experience (Subjective Rating Subscale 3) |
59.3; 47.5; 48.4; 48.1 | — |
| PRIMARY Cleanliness (Subjective Rating Subscale 4) |
72.4; 47.7; 70.5; 49.3 | — |
| PRIMARY Carbon Monoxide (CO) Boost |
4.6; 3.6; 5.0; 2.4 | — |
| SECONDARY Intensity |
15.2; 19.7; 12.7; 18.8 | — |
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).
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
- Use of menthol cigarettes as preferred/regular brand (defined as using >20% of the time).
- Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies).
- Enrollment or plans to enroll in a smoking cessation program in the next month.
- Provide an initial Carbon Monoxide (CO) reading < 5 parts per million (ppm).
Alcohol/Drugs
- History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
- Current alcohol consumption that exceeds 25 standard drinks/week.
Medical
- Women who are pregnant, planning a pregnancy, and/or lactating.
- 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.
- Color blindness.
- 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:
- Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
- 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.
Data sourced from ClinicalTrials.gov (NCT05157048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.