Choice-based harm-reduction sampling to help people not ready to quit smoking

Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit

This project will test whether letting smokers who aren't ready to quit choose and try a harm-reduction product (an e-cigarette or a nicotine pouch) leads to less cigarette use over six months than giving a nicotine patch plus lozenge.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 472 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Abramson Cancer Center at Penn Medicine (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07199517 on ClinicalTrials.gov

What this trial studies

Adults who smoke but do not want to quit will be randomized 2:1 to a choice-based harm-reduction product condition (choose between an e-cigarette or an oral nicotine pouch) or to a medicinal nicotine control (nicotine patch plus lozenge). Participants receive a four-week starter supply of the assigned products and are followed for six months to track product use and cigarette smoking behavior. The trial will examine behavioral and psychological mechanisms that may drive product uptake and reduced smoking, and test moderators that influence who benefits most. Recruitment targets a national sample of people unmotivated to quit, with study procedures coordinated by the University of Pennsylvania.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults (over 21) who smoke at least five cigarettes per day for six months or more, have CO ≥10 ppm, are not regularly using other nicotine products, and are not planning to quit in the next 30 days.

Not a fit: People already using other nicotine products regularly, those actively enrolled in a cessation program or using cessation medication, or those unwilling/unable to complete required testing or product use are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help people who are not ready to quit reduce their cigarette use by discovering a less harmful nicotine product that suits them.

How similar studies have performed: Prior work showed a four-week supply of e-cigarettes produced meaningful changes in smoking compared with no provision, but choice-based harm-reduction sampling is relatively novel and less tested.

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. Have a carbon monoxide (CO) greater than or equal to 10 ppm
4. Not using any forms of nicotine regularly other than cigarettes.
5. Not interested in quitting smoking in the next 30 days.
6. Capable of giving written informed consent, including 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, IQOS, ONPS, etc.).
2. Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.
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)

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, uncontrolled hypertension, cardiovascular event).

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 and/o. 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

• Principal investigator: Janet Audrain-McGovern, Ph.D. — University of Pennsylvania
• Study coordinator: Janet Audrain-McGovern, Ph.D.

Conditions Cigarette Smoking; Tobacco Use; Cigarette Smoking Behavior; cigarette smoking; harm reduction; sampling; nicotine replacement