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

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how e-cigarettes (ECIGS) and oral nicotine pouches (ONPS) might help people who smoke cigarettes switch to a less harmful option. The study will involve 200 smokers who have been smoking at least five cigarettes a day for the last six months and have tried to quit multiple times before. Participants will be assigned to either use e-cigarettes or nicotine pouches for six weeks instead of smoking regular cigarettes. The goal is to see which option helps reduce smoking and measures of nicotine exposure the most.

To join the study, you need to be over 21 years old, able to communicate in English, and willing to switch to e-cigarettes or nicotine pouches for the duration of the trial. You should also have a high enough level of carbon monoxide in your breath, which indicates recent smoking. This study is not suitable for pregnant individuals, those with certain health conditions, or anyone currently using other nicotine products. Participants will be monitored throughout the study, and they will have the opportunity to learn more about alternative nicotine options that could help them reduce their smoking.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • Smoking Behavior
• • 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.
• • a. Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible.
• • 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.
• • Alcohol and Drug
• • 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.
• • Medical
• • 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.
• • Psychiatric
• • 1. Lifetime history of schizophrenia or psychosis.
• • General Exclusion
• • 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.