Acute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure

NCT ID: NCT05157048

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2023-02-14

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).

Conditions

Smoking Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Light pack color

Participants will be randomized to one of two pack color conditions: light or dark. Those in the light pack color condition will be given Natural American Spirit Sky packs.

Group Type: EXPERIMENTAL

Charcoal-filtered cigarette

Intervention Type: OTHER

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Non-charcoal filtered cigarette

Intervention Type: OTHER

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Dark pack color

Participants will be randomized to one of two pack color conditions: light or dark. Those in the dark pack color condition will be given Natural American Spirit Black packs.

Group Type: EXPERIMENTAL

Charcoal-filtered cigarette

Intervention Type: OTHER

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Non-charcoal filtered cigarette

Intervention Type: OTHER

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Interventions

Charcoal-filtered cigarette

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Intervention Type: OTHER

Non-charcoal filtered cigarette

Participants will smoke two visually identical cigarettes, one with a charcoal filter and one with a non-charcoal filter, in counterbalanced order. The charcoal filter cigarette will be a Natural American Spirit Sky cigarette; the non-charcoal filter cigarette will be a Natural American Spirit Orange cigarette.

Intervention Type: OTHER

Other Intervention Names

Product; Product

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Andrew Strasser

Research Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB 849152

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 05021

Identifier Type: -

Identifier Source: org_study_id