Evaluating e-cigarettes and nicotine pouches for smokers

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

This study is testing whether e-cigarettes or nicotine pouches can help long-term smokers quit regular cigarettes and reduce their smoking habits over six weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Abramson Cancer Center at Penn Medicine (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06372899 on ClinicalTrials.gov

What this trial studies

This study investigates whether e-cigarettes (ECIGS) or oral nicotine pouches (ONPS) can effectively replace combustible cigarettes among persistent smokers. A total of 200 participants will be randomized to use either ECIGS or ONPS for six weeks after establishing a baseline smoking rate. The study will measure changes in smoking behavior and biomarkers of exposure to assess the harm reduction potential of these noncombustible alternatives. Additionally, subjective rewards and the reinforcing value of ECIGS and ONPS will be evaluated to understand factors influencing switching from cigarettes.

Who should consider this trial

Good fit: Ideal candidates are adults over 21 who smoke at least 5 cigarettes per day and have made multiple unsuccessful quit attempts.

Not a fit: Patients who regularly use other nicotine products or have not made prior quit attempts may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide smokers with effective alternatives to reduce harm associated with combustible cigarette use.

How similar studies have performed: Previous studies have shown promise in using noncombustible nicotine delivery systems for harm reduction, making this approach both relevant and potentially impactful.

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.

Where this trial is running

Philadelphia, Pennsylvania

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Janet Audrain-McGovern, Ph.D.

Conditions E-cigarette Use; Cigarette Smoking; Harm Reduction; Tobacco Use