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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07199517
Status
Recruiting

Conditions

  • Cigarette Smoking
  • Cigarette Smoking Behavior
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 12, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
472 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Smoking abstinence [ Time Frame: 29 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Janet Audrain-McGovern, Ph.D.
215-746-7145

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