Switch or Quit R01

NCT06373679 | Recruiting

• 2 other identifiers: Pro001255141R01DA056445-01A1
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Greater than 50% reduction in cigarette smoking

  11 Weeks

Study Arms (2)

Choice of Medication

EXPERIMENTAL

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

Choice of E-Cigarette

EXPERIMENTAL

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

Interventions

Switching to E-Cigarette BEHAVIORAL

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

Choice of E-Cigarette

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

Choice of Medication

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical Univeristy of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Tracy Smith

  smithtra@musc.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Smith, PhD

CONTACT

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

Merritt McDonald

CONTACT

(843)-876-2430; mcdoname@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 18, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)