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

NCT07199517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Pennsylvania

    collaborator OTHER

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Janet Audrain-McGovern, Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2030-01-31
Completion
2030-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199517 on ClinicalTrials.gov