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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

Qualifiers

Able to communicate fluently in English (i.e. speaking, writing, and reading)

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.

5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.

Have a carbon monoxide (CO) greater than 10 ppm.

Disqualifiers

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.

Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.

Current use of smoking cessation medication

Provide a CO breath test reading less than 10 ppm at Intake.

Trial design

Treatments tested in this trial

  • E-cigarettes
  • Oral nicotine pouches

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Abramson Cancer Center at Penn Medicine

Lead sponsor

University of Pennsylvania

Sponsor institution

National Cancer Institute (NCI)

Collaborator

University of Pennsylvania

Collaborator