Young Adults and Low Nicotine Cigarettes

NCT03699865 | Withdrawn

• 3 other identifiers: UPCC 100211K07CA218366-01A1829101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' 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.

Conditions

Smoking

Keywords

low nicotine; smoking behaviors; risk perceptions

Outcome Measures

Primary Outcomes (1)

• Daily cigarette consumption

  Daily cigarette consumption will be assessed primarily by participant self-report and secondarily through collection of spent filters for all cigarettes smoked during the 35-day study period, and will be averaged across baseline and pack color periods.

  Days 0 through 40

Secondary Outcomes (3)

• Total puff volume

  Days 0, 5, 10, 15, 20, 25, 30, 35, and 40

• Risk perceptions

  Days 10, 20, 30, and 40

• Harm exposure

  Days 0, 5, 10, 15, 20, 25, 30, 35, and 40

Study Arms (3)

Purple

EXPERIMENTAL

Participants will receive cigarettes with intermediate or very low nicotine content in purple packaging

Other: Nicotine content

White

EXPERIMENTAL

Participants will receive cigarettes with intermediate or very low nicotine content in white packaging

Other: Nicotine content

Black

EXPERIMENTAL

Participants will receive cigarettes with intermediate or very low nicotine content in black packaging

Other: Nicotine content

Interventions

Nicotine content OTHER

Study-supplied cigarettes will contain either intermediate or very low nicotine content

Black; Purple; White

Eligibility Criteria

• Age: 21 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Study participants will be 100 male and female young adult smokers who:
• Are aged 18-25
• Report smoking ≥ 100 lifetime cigarettes
• Report smoking at least 1 non-menthol, filtered cigarette per day

You may not qualify if:

• We will exclude those who:
• Plan to quit smoking in the next month
• Smoke menthol cigarettes \> 80% of the time
• Report consuming ≥ 25 alcohol-containing drinks per week
• Report a history or current psychiatric diagnosis or severe medical condition,
• Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
• Are pregnant and/or lactating
• Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
• Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
• Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Melissa Mercincavage, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be informed that they will be supplied cigarettes with low nicotine content but will be blinded to exact nicotine content and unaware that within-subject, all packages will contain the same type of low nicotine cigarette
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Randomized, single-blind, 2 x 4 mixed factorial design laboratory-based study manipulating: (1) cigarette pack color (4-level within-subjects factor: own brand vs. white vs. purple vs. black color), and (2) nicotine content (2-level between-subjects factor: moderate vs. very low nicotine content). All participants will provide and smoke their preferred brand for an initial 5-day baseline period, receiver their own brand free-of-charge for 5-days, and then will be randomly assigned to smoke either intermediate or very low LNC cigarettes for the study duration. We will supply participants with LNC cigarettes in three pack colors; each color will be used for a 10-day period, in counter-balanced order.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: October 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)