A Study of Unfiltered Cigarettes Among Committed Smokers

NCT03749876 | Completed DMC

• 1 other identifier: TRDRP Award #580582
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes There will be a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (determined at time of randomization), and a 3-week washout period, followed by post-washout baseline week, and a crossover to 2 weeks of smoking the opposite condition.

Conditions

Cigarette Smoking; Tobacco Smoking

Keywords

Cigarette filters; Cigarette smoking; Unfiltered cigarettes

Outcome Measures

Primary Outcomes (6)

• Change in mean flow rate (mL/s)

  Mean flow rate, in mL per second, measures the flow of air through the CReSS as participants smoke cigarettes.

  9 weeks

• Change in number of puffs per cigarette

  Measured by the CReSS device as participants smoke cigarettes

  9 weeks

• Change in duration of each cigarette puff (in seconds)

  Measured by the CReSS device as participants smoke cigarettes

  9 weeks

• Change in inter-puff interval in seconds

  The time between puffs on the cigarette, measured by the CReSS device as participants smoke cigarettes

  9 weeks

• Change in volume of each puff (mL)

  Measured by the CReSS device as participants smoke cigarettes

  9 weeks

• Change in total smoke intake (mL)

  Measured by the CReSS device as participants smoke cigarettes

  9 weeks

Secondary Outcomes (5)

• Urinary biomarker measurements

  9 weeks

• Cigarette satisfaction: mCEQ

  9 weeks

• Change in answers to Stanford Perceptions Survey of Youth questions

  9 weeks

• Change in perceptions of cigarette harshness

  9 weeks

• Change in perceptions of cigarette draw

  9 weeks

Study Arms (2)

Study Group 1

ACTIVE COMPARATOR

Study Group 1 will begin the first treatment period with the provided Unfiltered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Filtered Cigarette intervention for two weeks.

Other: Unfiltered Cigarettes; Other: Filtered Cigarettes

Study Group 2

EXPERIMENTAL

Study Group 2 will begin the first treatment period with the provided Filtered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Unfiltered Cigarette intervention for two weeks.

Other: Unfiltered Cigarettes; Other: Filtered Cigarettes

Interventions

Unfiltered Cigarettes OTHER

Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.

Study Group 1; Study Group 2

Filtered Cigarettes OTHER

Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.

Study Group 1; Study Group 2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are non-institutionalized, and
• Able to provide informed consent, and
• Are ages 21 to 65, and
• Smoke at least 25 days per month, and
• Smoke at least 5 cigarettes per day on the days they smoke, and
• Have been smoking cigarettes for at least 1 year, and
• Have smoked exclusively Camel or Pall Mall cigarettes over the past two weeks, or are willing to do so for the two weeks prior to, and for seven weeks during, the study, and
• Are fluent in English, and
• Have regular access to a telephone, and
• Have smoked only filtered cigarettes for the past year, and
• Have access to transportation to California State University, San Marcos (CSUSM), and
• Report primary (≥50% of the time) smoking of cigarettes, allowing for secondary use of other tobacco products, and
• Agree to the terms of the trial

You may not qualify if:

• Self-report uncontrolled diabetes (i.e., diagnosed with diabetes, and it is not being managed by a physician), or
• Present to the enrollment visit with a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 105 mm Hg, or
• Self-report involvement in another clinical trial, or
• Self-report hospitalization for psychiatric issues or had a heart-related event (e.g. heart attack) at enrollment or within the past 30 days, or
• Self-report attempts to quit or cut down on smoking in past 30 days, or
• Self-report use of pharmacotherapy to aid smoking cessation within the past 30 days, or
• Are breastfeeding, pregnant, or may become pregnant during the next six months, or
• Are planning to move out of San Diego in the next 9 weeks, or
• Do not meet expected expired carbon monoxide (CO) measurements of smokers (Expired CO measurements\>10 parts per million (ppm) will confirm status as a current smoker of at \>5 cigarettes/day on the initial visit), or
• Are deemed mentally unstable (i.e., psychotic, under influence of drugs or alcohol, or unable to comprehend the call or meeting) or physically unfit (i.e, physically unwell) to participate in the study based on the researcher's determination at the enrollment visit

Sponsors & Collaborators

• San Diego State University: lead
• California State University, San Marcos: collaborator
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

California State University San Marcos

San Marcos, California, 92096, United States

Location

Related Publications (49)

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• Pulvers K, Tracy L, Novotny TE, Satybaldiyeva N, Hunn A, Romero DR, Dodder NG, Magraner J, Oren E. Switching people who smoke to unfiltered cigarettes: perceptions, addiction and behavioural effects in a cross-over randomised controlled trial. Tob Control. 2023 Jul;32(4):520-523. doi: 10.1136/tobaccocontrol-2021-056815. Epub 2021 Nov 19.

  PMID: 34799433 DERIVED

• Oren E, Pulvers K, Romero DR, Barber C, Carter E, Tracy LA, Novotny TE. Effects of Unfiltered Cigarettes on Smoking Behavior and Toxicant Exposure: Protocol for a Randomized Crossover Clinical Trial. JMIR Res Protoc. 2020 Dec 8;9(12):e19603. doi: 10.2196/19603.

  PMID: 33289680 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Study Officials

• Eyal Oren, Ph.D.

  San Diego State University School of Public Health

  PRINCIPAL INVESTIGATOR

• Kimberly Pulvers, Ph.D.

  California State University, San Marcos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research staff performing the statistical analyses of the outcomes of interest will be masked from knowing the individuals' randomized treatment assignments, as will the principal investigator.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 21, 2018
• Study Start: January 17, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)