Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT06373679

Conditions

Cigarette Smoking

Smoking Behaviors

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Switching to E-Cigarette

Switching using Medication

Study Details

Brief summary:

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.

Conditions

Cigarette Smoking

Smoking Behaviors

Study ID

NCT06373679

Start date

Jul 10, 2024

Status verified date

Jul, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria

  • Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.
  • Interest in reducing harms from tobacco use or quitting smoking

Exclusion Criteria

  • Pregnant, breastfeeding, or trying to become pregnant.
  • Household member currently enrolled in the study
  • Planning to move out of the area within the next 7 months

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Switching to E-Cigarette

Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date

Switching using Medication

Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tracy Smith, PhD

(843)-792-5164smithtra@musc.edu

Hana Thamer

(843)-876-2430thamer@musc.edu

Locations

Medical Univeristy of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Tracy Smith, PhD

8437925164smithtra@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-13.