RECRUITING

Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

Conditions

E-cigarette Use Cigarette Smoking Harm Reduction Tobacco Use

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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

This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms.

Official Title

Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

Quick Facts

Study Start:2024-10-02

Study Completion:2028-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06372899

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able to communicate fluently in English (i.e. speaking, writing, and reading) 2. Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. 3. 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt. 4. Have a carbon monoxide (CO) greater than 10 ppm. 5. Not using any forms of nicotine regularly other than cigarettes 6. Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks. 7. Plan to live in the area for the duration of the study. 8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.	1. Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days. 2. Current enrollment or plans to enroll in a smoking cessation program over the duration of the study. 3. Current use of smoking cessation medication 4. Provide a CO breath test reading less than 10 ppm at Intake. 1. History of substance abuse (other than nicotine dependence) in the past 12 months. 2. Current alcohol consumption that exceeds 20 standard drinks/week. 3. Current use of recreational drugs (other than nicotine and cannabis) 4. Breath alcohol reading (BrAC) greater than .000 at Intake. 1. Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period. 2. Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator. 1. Lifetime history of schizophrenia or psychosis. 1. 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. 2. Any 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. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen. 3. Significant non-compliance with protocol and/or study design as determined by the Principal Investigator. Subjects may be deemed ineligible at any point throughout the study.

Inclusion Criteria

Exclusion Criteria

1. Able to communicate fluently in English (i.e. speaking, writing, and reading)
2. Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
3. 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
4. Have a carbon monoxide (CO) greater than 10 ppm.
5. Not using any forms of nicotine regularly other than cigarettes
6. Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks.
7. Plan to live in the area for the duration of the study.
8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

1. Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days.
2. Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
3. Current use of smoking cessation medication
4. Provide a CO breath test reading less than 10 ppm at Intake.
1. History of substance abuse (other than nicotine dependence) in the past 12 months.
2. Current alcohol consumption that exceeds 20 standard drinks/week.
3. Current use of recreational drugs (other than nicotine and cannabis)
4. Breath alcohol reading (BrAC) greater than .000 at Intake.
1. Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
2. Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
1. Lifetime history of schizophrenia or psychosis.
1. 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.
2. Any 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. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
3. Significant non-compliance with protocol and/or study design as determined by the Principal Investigator. Subjects may be deemed ineligible at any point throughout the study.

Contacts and Locations

Study Contact

Janet Audrain-McGovern, Ph.D.

CONTACT

215-746-7145

audrain@pennmedicine.upenn.edu

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

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 Date2024-10-02

Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-10-02

Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

E-cigarette Use
Cigarette Smoking
Harm Reduction
Tobacco Use