Switch or Quit R01

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06373679
Status
Recruiting
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Conditions

  • Cigarette Smoking
  • Smoking Behaviors

Eligibility Criteria

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

Interventions

  • Switching to E-Cigarette — BEHAVIORAL
    Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
  • Switching using Medication — BEHAVIORAL
    Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date

Study Details

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Key Dates

Start date
Jul 10, 2024
Status verified
Jul 2025
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Choice of Medication
    This arm includes participants randomly assigned to the Meds Group. Participants will choose between 1) combo NRT and 2) varenicline. The NRT will consist of transdermal NRT and nicotine lozenge. Participants will receive study product for 11 weeks.
  • Experimental: Choice of E-Cigarette
    This arm includes participants randomly assigned to the E-Cigarette Group. Participants will choose between two different brands of e-cigarettes and choose up to two different flavors. Participants will receive study product for 11 weeks.

Primary Outcome Measure

Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback [ Time Frame: 11 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical Univeristy of South CarolinaCharlestonSouth Carolina29425
Tracy Smith, PhD
[email protected]
843-792-5164

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By research site
Medical Univeristy of South Carolina· Charleston, SC

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