Quit or Switch: E-cigarette Study

E-cigarettes as Harm Reduction Tools in Smokers Who Fail to Quit With Traditional Methods

The majority of smokers try to quit each year, and the majority of quit attempts fail, even when the most effective FDA-approved pharmacotherapies are used. Non-combustible tobacco products emit fewer harmful chemicals than cigarettes, and thus for smokers who cannot quit smoking, switching completely to a less harmful product is likely to improve their risk of cancer and other deleterious health outcomes. E-cigarettes, the most commonly used non-cigarette tobacco product, have been shown to deliver sufficient nicotine, be appealing to smokers, and reduce cigarette smoking when provided to smokers to use ad libitum. For smokers who have failed to quit with traditional methods, trying to switch to a less harmful product may be more likely to help them stop smoking than trying to quit using tobacco altogether repeatedly with pharmacotherapy. The proposed trial evaluates the potential of e-cigarettes to serve as harm reduction tools for current smokers who have already tried, and failed, to quit with traditional methods. Current smokers who failed to quit with FDA-approved pharmacotherapy within the past year (N=30) will be randomly assigned to either 1) switch completely to e-cigarettes (Switch Group, n=20), or 2) try to quit again using pharmacotherapy (Meds Group, n=10). Thus, our design is strengthened by a strong active control group. Participants will select a Target Switch / Quit Date on which they will stop smoking. Participants in the Switch group will receive a 5-week supply of JUUL e-cigarettes, the most popular e-cigarette currently available. Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge). Participants will use 1-week of their tobacco product or medication ad libitum while continuing to smoke in advance of their Target Switch / Quit Date, and 4-weeks as instructed following a Target Switch or Quit Date. Behavioral outcomes of interest include smoking reduction > 50% and biochemically-confirmed abstinence from cigarette smoking at 4-weeks. The proposed trial addresses a highly significant research question using a rigorous design and is supported by a strong investigative team.

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: e-cigarette; Other: Nicotine patch, Nicotine lozenge

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: J'Neice Payne; Phone Number: 843-876-2291; Email: paynejne@musc.edu
• Study Contact Backup: Name: Tracy Smith, PhD; Phone Number: 843-792-5164; Email: smithtra@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 21 years old
2. Smoking at least 5 cigarettes per day for 1 year
3. A quit attempt using an FDA-approved pharmacotherapy in the past year that resulted in abstinence of at least 24 hours
4. Intention to quit smoking within the next month
5. Access to daily e-mail or a smartphone that receives text messages

Exclusion Criteria:

1. use of non-cigarette tobacco products in the past 30 days
2. current use of pharmacotherapy for smoking cessation
3. pregnant, breastfeeding, or trying to become pregnant
4. household member currently enrolled in the study
5. contraindicated for NRT
6. planning to move out of the area within the next 6 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: Switch Group; Participants in the Switch group will receive a 5-week supply of e-cigarettes.	Behavioral: e-cigarette; Participants will select a Target Switch on which they will stop smoking cigarettes and switch entirely to the e-cigarette product.
Active Comparator: Meds Group; Participants in the Meds Group will receive a 5-week supply of combination nicotine replacement therapy (transdermal nicotine patch and short-acting nicotine lozenge).	Other: Nicotine patch, Nicotine lozenge; Participants will select a Target Quit Date on which they will stop smoking, using the patches and lozenges provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Report Daily Use of E-cigarettes or NRT and no Cigarette Use	daily use of e-cigarette or NRT instead of cigarettes	day 0 through day 35
Percentage of Participants Who Have Biochemically-confirmed Abstinence From Cigarette Smoking at Week 4	Self reported point prevalence abstinence from cigarettes and expired carbon monoxide < 6 ppm	Week 4

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: PRO#00118102

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