RECRUITING

Cigarette Packaging of Low Nicotine Cigarettes

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes

Quick Facts

Study Start:2019-09-18

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03802019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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. * 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.

Inclusion Criteria

Exclusion 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).

* 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.
* 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.

Contacts and Locations

Study Contact

Catherine Kreider

CONTACT

215-746-2631

cathk@pennmedicine.upenn.edu

Valentina Souprountchouk

CONTACT

215-746-3602

vsoup@pennmedicine.upenn.edu

Principal Investigator

Andrew Strasser, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Center for Interdisciplinary Research for Nicotine Addiction

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Andrew Strasser, Ph.D., PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-18

Study Completion Date2025-09

Study Record Updates

Study Start Date2019-09-18

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Smoking Behavior

Additional Relevant MeSH Terms

Smoking, Cigarette