Cigarette Packaging of Low Nicotine Cigarettes
Cigarette Packaging of Low Nicotine Cigarettes
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.
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 in-person sessions at the Center for Interdisciplinary
 Research on Nicotine Addiction (CIRNA) every 4-6 days, for a total of 8 in-person sessions
 across 35 days.
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.

 -  Provide a breath alcohol concentration (BrAC) reading greater than .000 at Day 0.

 -  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.