Acute Cigarette Evaluation Study

Smoking Behaviors Clinical Trial

— SKY Pilot  

Official title:

Acute Effects of Commercially-available Cigarettes on Perceptions, Use Behaviors, and Harm Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157048
• Other study ID #: 849152
• Secondary ID: UPCC 05021
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: March 2023
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single laboratory session pilot study will examine the acute effects of commercially available cigarettes on adult smokers' 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.

Description:

In some research studies, the investigators cannot tell participants exactly what the study is about before they participate in the study. Study tasks will be described in this document in a general way, but participants will not be told the real purpose of the study until after they complete the study. The purpose of this study is broadly to learn more about how people who smoke evaluate different types of commercial cigarettes. The investigators are interested in how the marketing and design of different products affect perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.

After completing the study, the investigators will explain why they are doing this study, what they are looking at, and address any other questions. Although the real purposes of the study will not be explained until after participants complete the study, there are no additional risks to those described in the study consent form.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Behaviors

Intervention

Other:
• Cigarette A
Participants will be smoke a first type of blinded commercially available cigarette.
• Cigarette B
Participants will smoke a second type of blinded commercially available cigarette.

Locations

Country	Name	City	State
United States	Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in video-scored smoking behavior from Cigarette 1 to Cigarette 2	Participants' puffing behavior will be collected using a validated procedure to score video recorded smoking sessions.	Session 1; assessed while smoking Cigarette 1 (45 min after session begins) and Cigarette 2 (90 min after session begins)
Primary	Change in cigarette purchase task behaviors from Cigarette 1 to Cigarette 2	Behavioral economic indices of demand will be measured using a hypothetical purchase task. Participants will be asked how many cigarettes (preferred brand and study-supplied) they would purchase and consume in the next 30 days across a range of prices, from free up to high amounts at which purchase/consumption is expected to drop off.	Session 1; assessed after smoking Cigarette 1 (45 min after session begins), and Cigarette 2 (90 min after session begins)
Primary	Change in risk beliefs from Cigarette 1 to Cigarette 2	A previously validated 8-item scale17-19 will be administered at the beginning of the study session (regarding their own brand) and after each cigarette smoked in the laboratory (regarding these cigarettes), while physically viewing the pack, to assess participant's perceptions of harms from using the product. We will examine both a summed composite score and individual items rated on a 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") that evaluate participants' preferred brand and the cigarettes they smoked on the following beliefs: a) "lower in nicotine", b) "lower in tar", c) "less addictive", d) "less likely to cause cancer", e) "has fewer chemicals", f) "is healthier", g) "makes smoking safer", h) "helps people quit smoking."	Session 1; assessed after smoking Cigarette 1 (45 min after session begins) and Cigarette 2 (90 min after session begins)
Primary	Change in perceived health risks from Cigarette 1 to Cigarette 2	At the beginning of the study session and after using each laboratory cigarette, participants will complete a 13-item measure20 asking them to indicate on a 7-point Likert scale (1 = "very low risk", 7 = "very high risk") their risk of developing 11 health conditions (i.e., lung cancer, heart disease, stroke, high blood pressure, diabetes, asthma, liver disease, emphysema, respiratory infections, other cancers, and addiction) based on regular use of their preferred brand and each cigarette they sampled. Two additional items will ask about overall risks of using the cigarettes for themselves and for others.	Session 1; assessed after smoking Cigarette 1 (45 min after session begins) and Cigarette 2 (90 min after session begins)
Primary	Change in subjective ratings from Cigarette 1 to Cigarette 2	Subjective ratings will be measured after each cigarette smoked during in-person visits using 14 individual items assessing various cigarette characteristics (e.g., strength) used by the tobacco industry and our laboratory.17,21-23 Items are rated on a 100 mm visual analog scale with item-specific anchors (e.g., strength: 0 = "very weak," 100 = "very strong"); lower scores indicate less favorable ratings.	Session 1; assessed after smoking Cigarette 1 (45 min after session begins) and Cigarette 2 (90 min after session begins)
Primary	Change in carbon monoxide boost from Cigarette 1 to Cigarette 2	CO will be measured in parts per million (ppm) using the Vitalograph BreathCO carbon monoxide monitor (Lenexa, KS) at the onset of the laboratory visit, as well as before and after each cigarette smoked. CO boost - the change in CO values resulting from smoking a cigarette - crudely estimates smoke exposure due to smoking an individual cigarette.	Session 1; assessed before & after smoking Cigarette 1 (45 min after session begins) and Cigarette 2 (90 min after session begins)