Cigarette Packaging of Low Nicotine Cigarettes

NCT ID: NCT03802019

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2025-08-27

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.

Conditions

Smoking, Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Own Brand

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).

Group Type: EXPERIMENTAL

Own Brand

Intervention Type: 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).

LNC Cigarettes + Gray Packaging

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).

Group Type: EXPERIMENTAL

LNC Cigarettes + Colored Packaging

Intervention Type: 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 + Red Packaging

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.

Group Type: EXPERIMENTAL

LNC Cigarettes + Colored Packaging

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

LNC Cigarettes + Colored Packaging

Intervention Type: 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 + Plain Packaging

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.

Group Type: EXPERIMENTAL

LNC Cigarettes + Colored Packaging

Intervention Type: 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.

Interventions

LNC Cigarettes + Colored Packaging

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.

Intervention Type: OTHER

Own Brand

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Strasser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Center for Interdisciplinary Research for Nicotine Addiction

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

1U54CA229973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

832540

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 13019

Identifier Type: -

Identifier Source: org_study_id