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

NCT06372899 | Recruiting

• 3 other identifiers: UPCC 02024R01CA290541-01A1855140
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Cigarette Consumption

  The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49).

  42 days (days 8 - 49)

• Cigarette Smoking Across Follow-Up

  Average cigarettes per day at the 6-month follow-up is a secondary endpoint, measured by the valid and reliable timeline follow-back (TLFB) interview.

  19 Weeks (Day 50-6-Month Follow-Up)

Secondary Outcomes (4)

• Biomarkers of Exposure: Carbon Monoxide (CO)

  49 days (days 1-49)

• Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%)

  49 days (days 1-49)

• Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

  49 days (days 1-49)

• Biomarkers of Exposure:1-hydroxypyrene (1-HOP)

  49 days (days 1-49)

Study Arms (2)

ECIGS

EXPERIMENTAL

Participants randomized to ECIGS will be provided with an e-cigarette device and be instructed to switch from smoking combustible cigarettes to using only the study-provided e-cigarette device. Participants will be able to choose between Tobacco, Menthol, Watermelon, and Blueberry flavored nicotine pods. They will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behavior.

Other: E-cigarettes

ONPS

EXPERIMENTAL

Participants randomized to ONPS will be provided with oral nicotine pouches and be instructed to switch from smoking combustible cigarettes to using only the study-provided nicotine pouches. Participants will be able to choose between Original, Mint, Berry, and Citrus flavored nicotine pouches. They will receive their supply of nicotine pouches in 7-day increments, based on baseline smoking behavior.

Other: Oral nicotine pouches

Interventions

E-cigarettes OTHER

Participants randomized to ECIGS are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. They will be provided with an e-cigarette device and nicotine pods.

ECIGS

Oral nicotine pouches OTHER

Participants randomized to ONPS are instructed to switch from smoking combustible cigarettes to using nicotine pouches for 6 weeks. They will be provided with nicotine pouches.

ONPS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Not using any forms of nicotine regularly other than cigarettes
• Be willing to switch to e-cigarettes or nicotine pouches for 6 weeks.
• Plan to live in the area for the duration of the study.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

You may not qualify if:

• Smoking Behavior
• 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.
• 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.
• Alcohol and Drug
• History of substance abuse (other than nicotine dependence) in the past 12 months.
• Current alcohol consumption that exceeds 20 standard drinks/week.
• Current use of recreational drugs (other than nicotine and cannabis)
• Breath alcohol reading (BrAC) greater than .000 at Intake.
• Medical
• Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Cigarette Smoking; Harm Reduction; Tobacco Use

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Janet Audrain-McGovern, Ph.D.

CONTACT

215-746-7145; audrain@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 18, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)