Recruiting

ECIG & NPL

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07199517

Conditions

Cigarette Smoking

Tobacco Use

Cigarette Smoking Behavior

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

HRP Sampling period

NPL Sampling period

Study Details

Brief summary:

This study aims to investigate harm-reduction sampling in a choice format versus medicinal nicotine sampling on smoking behavior, identify mechanisms of sampling's effects, and explore moderators of these effects among a national sample of people unmotivated to quit smoking. Participants will be randomized 2:1 to choose one of two harm-reduction products (ECIG, ONP) versus a medicinal nicotine control condition (nicotine patch + lozenge, NPL), receive a 4-week starter product regimen, and then be followed for 6 months to assess use behavior.

Conditions

Cigarette Smoking

Tobacco Use

Cigarette Smoking Behavior

Study ID

NCT07199517

Start date

Jan 12, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

472 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Harm Reduction Products (HRP)

Participants randomized to HRP will try and rate ECIGS and ONPS during 2 virtual visits, and receive a 4-week supply of their preferred HRP (ECIGS or ONPs) for the sampling period.

active comparator: Nicotine Patch and Lozenge (NPL)

Participants randomized to NPL will try a nicotine patch and nicotine lozenge during 1 virtual lab visit and will receive a 4-week supply of nicotine patches and lozenges for the sampling period.

Interventions

HRP Sampling period

During a 28-day sampling period, participants randomized to HRP are instructed to try their selected HRP (ECIGS or ONPs) and will complete daily e-diaries of cigarette smoking behavior and product uptake.

NPL Sampling period

During a 28-day sampling period, participants randomized to NPL are instructed to try nicotine patches and nicotine lozenges and will complete daily e-diaries of cigarette smoking behavior and product uptake.

Primary outcome measure

  • Smoking abstinence [ Time Frame: 29 weeks ]

Central Contacts and Locations

Central contacts

Janet Audrain-McGovern, Ph.D.

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Janet Audrain-McGovern, Ph.D.

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

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • cigarette smoking
  • harm reduction
  • sampling
  • nicotine replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-11.