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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: audrain@pennmedicine.upenn.edu
• Phone: 215-746-7145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.