The Options 2 Study

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06595459
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Smoker
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicotine Pouches — DRUG
    3mg or 6mg nicotine pouches
  • Mini Nicotine lozenges — DRUG
    2mg to 4mg mini lozenges

Study Details

The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products. Participants will: * Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use

Key Dates

Start date
May 21, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2029
Completion
Jul 30, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3mg Nicotine Pouches
    Participants will use 3mg nicotine pouches
  • Experimental: 6mg Nicotine Pouches
    Participants will use 6mg nicotine pouches
  • Experimental: Nicotine Mini Lozenges
    Participants will use mini lozenges with dosing based on time to first cigarette (2mg - 4mg)
  • No Intervention: No Study Product
    Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.

Primary Outcome Measure

Mean number of cigarettes smoked per day during the 21-day switching period. [ Time Frame: Baseline to 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Megan Piper, PhD
[email protected]
608-265-5472

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By research site
University of Wisconsin· Madison, WI

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