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The Options 2 Study

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Site contact updatedv10
  3. Site contact updatedv9
  4. Primary completion date: Oct 2026 to Jan 1, 2029
    • Study completion date: Oct 2026 to Jul 30, 2029
    v8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2025 to May 21, 2025
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Site contact updatedv5
  3. Secondary endpoints: 2 to 3
    • Site contact updated
    v4
  4. Site contact updated
    • Collaborators: 1 to 2
    v3
  5. Primary endpoint revised
    • Site contact updated
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06595459
Lead Sponsor University of Wisconsin, Madison
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions
(from sponsor)		 Smoker, Smoking Cessation
Related terms Smoking Cessation
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov