Switch or Quit R01

Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking; Smoking Behaviors
• Intervention / Treatment: Behavioral: Switching using Medication; Behavioral: Switching to E-Cigarette

Detailed Description

Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking.

These data are urgently needed for several reasons.

1. Clinicians cannot provide clear guidance to smokers who may be interested in switching. Questions from medical patients about e-cigarettes are on the rise, and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes, with some physicians discouraging their use and some recommending them as cessation aids.
2. Public health organizations are also providing mixed messages about the health risks of non-cigarette tobacco products-with some not recommending their use at all (The American Cancer Society, American Lung Association), and some acknowledging that complete switching to e-cigarettes would reduce health risks compared to continued smoking, but not recommending the use of these products over traditional methods (Centers for Disease Control, Food and Drug Administration).
3. In the absence of clear messaging about non-cigarette products, smokers who fail with traditional methods are continuing to smoke cigarettes, the most harmful tobacco product available.

The reviews underscore the need for additional data on this topic, especially data comparing the products to pharmacotherapy. The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products (e-cigarettes) have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tracy Smith, PhD; Phone Number: (843)-792-5164; Email: smithtra@musc.edu
• Study Contact Backup: Name: Merritt McDonald; Phone Number: (843)-876-2430; Email: mcdoname@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical Univeristy of South Carolina
      • Contact: Tracy Smith, PhD; Phone Number: 843-792-5164; Email: smithtra@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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
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.	Behavioral: Switching to E-Cigarette; Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback	Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide < 6 ppm	11 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Greater than 50% reduction in cigarette smoking	Average reduction in the number of cigarettes smoked per day on 7-day timeline followback at Week 11 of at least 50% or greater compared to average baseline number of cigarettes smoked per day on 7 day timeline followback	11 Weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tracy Smith, smithtra@musc.edu

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00125514; 1R01DA056445-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No