Cigarette Packaging of Low Nicotine Cigarettes

NCT03802019 | Completed

• 3 other identifiers: UPCC 130191U54CA229973832540
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of changes in cigarette package color on smoking behaviors, harm exposure, and risk perceptions when using low nicotine content (LNC) cigarettes.

Conditions

Smoking, Cigarette

Keywords

Smoking Behavior

Outcome Measures

Primary Outcomes (5)

• Daily Cigarette Consumption

  Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters for all cigarettes smoked throughout the entire 35-day study.

  Day 0 through Day 35

• Total Puff Volume/Puff Duration

  Total puff volume/puff duration (the sum of all puff volumes/duration per cigarette) will be collected for each cigarette smoked during each laboratory session using a standardized video scoring procedure. Total puff volume will be assessed for each cigarette smoked at in-person and remote sessions throughout the entire 35-day study.

  Day 0 through Day 35

• Carbon Monoxide (CO)

  The investigators will assess CO (measured in parts per million \[ppm\]), a measure of toxicant exposure, at the onset of each session, as well as before and after each cigarette smoked during each in-person laboratory session. CO collected at the onset of each session represents daily exposure, while CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette.

  Days 0, 5, 10, 20 and 35

• Total Nicotine Equivalents

  Urine collected at Day 5 and Day 35 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-35). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).

  Days 5 and 35

• Total NNAL

  Urine collected at D5 and D35 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-35). Total NNAL will be measured in nanograms per milliliter (ng per mL).

  Days 5 and 35

Secondary Outcomes (6)

• Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)

  Days 0, 5, 10, 20 and 35

• Cigarette Risk Beliefs

  Days 0, 5, 20, and 35

• Cigarette Craving (Questionnaire on Smoking Urges [QSU])

  Days 0, 5, 10, 20 and 35

• Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])

  : Days 0, 5, 10, 20 and 35

• Total Puff Count

  Day 0 through Day 35

Study Arms (5)

Own Brand

EXPERIMENTAL

After completing a 5-day baseline period of smoking their own brand, participants will complete a 30-day experimental period when they will continue to receive their own preferred brand of cigarettes (i.e., control group).

Other: Own Brand

LNC Cigarettes + Gray Packaging

EXPERIMENTAL

After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in standard investigational packaging (gray).

Other: LNC Cigarettes + Colored Packaging

LNC Cigarettes + Red Packaging

EXPERIMENTAL

After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in red packaging.

Other: LNC Cigarettes + Colored Packaging

LNC Cigarettes + Blue Packaging

EXPERIMENTAL

After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in blue packaging.

Other: LNC Cigarettes + Colored Packaging

LNC Cigarettes + Plain Packaging

EXPERIMENTAL

After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in plain packaging.

Other: LNC Cigarettes + Colored Packaging

Interventions

Own Brand OTHER

After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive their own preferred brand of cigarette (i.e., control).

Own Brand

LNC Cigarettes + Colored Packaging OTHER

After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in one of four types of packaging: gray, red, blue, or plain.

LNC Cigarettes + Blue Packaging; LNC Cigarettes + Gray Packaging; LNC Cigarettes + Plain Packaging; LNC Cigarettes + Red Packaging

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months.
• Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (\~5 weeks).
• Plan to live in the area for the duration of the study.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
• Able to communicate fluently in English (i.e., speaking, writing, and reading).

You may not qualify if:

• Smoke menthol cigarettes greater than 20% of the time.
• Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.)
• Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
• Attempt to quit smoking over the duration of the study period.
• Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0).
• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
• Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
• Color blindness.
• Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
• Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
• Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
• 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 circumstance, 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. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Food and Drug Administration (FDA): collaborator
• National Cancer Institute (NCI): collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Center for Interdisciplinary Research for Nicotine Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Andrew Strasser, Ph.D.

  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 with study cigarettes with a low nicotine content, but will be blinded to the exact nicotine content and unaware that all packages will contain the same type of low nicotine content cigarette.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project will recruit current, daily cigarette smokers to a 35-day, randomized, controlled, parallel design protocol. After a 5-day period of smoking their own preferred brand cigarettes, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control group), or LNC cigarettes in one of four types of packaging: standard investigational (current gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy), for 30 days.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 14, 2019
• Study Start: September 18, 2019
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)