Clinical trial NCT03802019: Cigarette Packaging of Low Nicotine Cigarettes
Official title: The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking, Cigarette
Keywords: Smoking Behavior
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
name: National Cancer Institute (NCI)
name: University of Pennsylvania
First posted: 2019-01-14
Enrollment: 575
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: This project will utilize a randomized, parallel-design trial to examine the effects of low nicotine content (LNC) cigarette packaging on smoking behaviors, harm exposure, risk perceptions, and subjective ratings of cigarettes. The investigators will aim to recruit and randomize 500 daily smokers (\~250 male, \~250 female) in a 35-day protocol. 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 either their own preferred brand (control), or LNC cigarettes in one of four types of packaging: standard investigational (gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy). Participants will be asked to attend 5 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 5, 10, 20 \& 35. At Intake and Days 15, 25 and 30 participants will complete sessions with research staff remotely (i.e. by video call). Sessions will occur every 4-6 days, for a total of 5 in-person and 4 remote sessions across 35 days.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Additional, general reasons for exclusion include:

* 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.
* Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn at any point throughout the study.

Primary outcomes:
measure: Daily Cigarette Consumption
timeFrame: Day 0 through Day 35
measure: Total Puff Volume/Puff Duration
timeFrame: Day 0 through Day 35
measure: Carbon Monoxide (CO)
timeFrame: Days 0, 5, 10, 20 and 35
measure: Total Nicotine Equivalents
timeFrame: Days 5 and 35
measure: Total NNAL
timeFrame: Days 5 and 35
Secondary outcomes:
measure: Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)
timeFrame: Days 0, 5, 10, 20 and 35
measure: Cigarette Risk Beliefs
timeFrame: Days 0, 5, 20, and 35
measure: Cigarette Craving (Questionnaire on Smoking Urges [QSU])
timeFrame: Days 0, 5, 10, 20 and 35
measure: Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])
timeFrame: : Days 0, 5, 10, 20 and 35
measure: Total Puff Count
timeFrame: Day 0 through Day 35
measure: Puff Duration
timeFrame: Day 0 through Day 35
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research for Nicotine Addiction
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Strasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: