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

NCT07199517 | Recruiting

• 3 other identifiers: UPCC180251R01CA302758-01858599
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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

Keywords

cigarette smoking; harm reduction; sampling; nicotine replacement

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence

  Seven-day point prevalence smoking abstinence (CO \< 5) will be measured at the 3-month (secondary endpoint) and 6-month follow-up (primary endpoint) via the valid and reliable TLFB procedure and biochemically verified through a CO \< 5 ppm.

  29 weeks

Secondary Outcomes (2)

• Smoking reduction

  29 weeks

• 24-hour quit attempts

  29 weeks

Study Arms (2)

Harm Reduction Products (HRP)

EXPERIMENTAL

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.

Other: HRP Sampling period

Nicotine Patch and Lozenge (NPL)

ACTIVE COMPARATOR

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.

Other: NPL Sampling period

Interventions

NPL Sampling period OTHER

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.

Nicotine Patch and Lozenge (NPL)

HRP Sampling period OTHER

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.

Harm Reduction Products (HRP)

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.
• Have a carbon monoxide (CO) greater than or equal to 10 ppm
• Not using any forms of nicotine regularly other than cigarettes.
• Not interested in quitting smoking in the next 30 days.
• Capable of giving written informed consent, including 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, IQOS, ONPS, etc.).
• Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.
• 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)
• 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, uncontrolled hypertension, cardiovascular event).
• Psychiatric
• \. Lifetime history of schizophrenia or psychosis.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use; Harm Reduction

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior

Study Officials

• Janet Audrain-McGovern, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)