Quit Smoking Study for People Who Use E-Cigarettes

NCT04946825 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STUDY00001059
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). The investigators will recruit participants using national advertising strategies. All treatment will be provided remotely in order to increase treatment access and comply with current COVID-19 restrictions.

Conditions

Nicotine Addiction; E-Cig Use; Quitting Smoking

Outcome Measures

Primary Outcomes (3)

• Biochemically Confirmed 7-day Point-prevalence Cigarette Abstinence

  The investigators will report breath carbon monoxide (CO; \<6 ppm) confirmed 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.

  End of treatment (ie., the 3 month follow up)

• Self-reported 7-day Point-prevalence Cigarette Abstinence

  The investigators will report self-reported 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.

  End of treatment (ie., the 3 month follow up)

• Adverse Events During Treatment

  Total number of participants who reported any adverse event during the 3-month treatment period.

  The 3 month treatment period.

Secondary Outcomes (5)

• Biochemically Confirmed Prolonged 30-day Abstinence

  The 3-month follow up (ie., end of treatment)

• Self-reported Prolonged 30-day Abstinence

  The 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment).

• Any Attempts to Quit Combustible Cigarettes

  The 3-month treatment period.

• Cigarettes Per Day

  The 3-month treatment period.

• Cigarette Dependence

  The 3-month treatment period.

Study Arms (4)

Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support

EXPERIMENTAL

Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.

Drug: Nicotine replacement therapy patch; Drug: Nicotine replacement therapy lozenge; Behavioral: Continue electronic cigarettes

Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.

EXPERIMENTAL

Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.

Drug: Nicotine replacement therapy patch; Drug: Nicotine replacement therapy lozenge; Behavioral: Quit electronic cigarettes

Quit cigarettes, but continue using e-cigarettes, with text support.

EXPERIMENTAL

Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.

Behavioral: Continue electronic cigarettes

Quit cigarettes and quit e-cigarettes with text support.

EXPERIMENTAL

Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.

Behavioral: Quit electronic cigarettes

Interventions

Nicotine replacement therapy patch DRUG

The nicotine patch is attached to the participant's skin and provides a slight constant stream of nicotine. The smaller dose is meant to reduce nicotine dependence.

Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.; Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support

Nicotine replacement therapy lozenge DRUG

The nicotine lozenge contains small amounts of nicotine, which a participant slowly dissolves in their mouth. Like the patch, the smaller dose is meant to reduce nicotine dependence.

Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.; Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support

Quit electronic cigarettes BEHAVIORAL

Participants will receive instruction and text message support to quit electronic cigarettes when they quit combustible cigarettes.

Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.; Quit cigarettes and quit e-cigarettes with text support.

Continue electronic cigarettes BEHAVIORAL

Participants will receive instruction and text message support to continue using electronic cigarettes after they quit combustible cigarettes.

Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support; Quit cigarettes, but continue using e-cigarettes, with text support.

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young adult
• Smokes tobacco cigarettes
• Uses electronic cigarettes
• Interested in quitting tobacco

You may not qualify if:

• Pregnant or planning to become pregnant
• Breastfeeding or planning to start breastfeeding
• One or more contraindications for nicotine replacement therapy
• Additional criteria will be assessed to determine eligibility.
• If you are interested in participating, please visit the study website to find out if you are eligible: https://www.uvmquitsmokingstudy.org/

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Health Behavior

Results Point of Contact

• Title: Elias Klemperer, PhD
• Organization: University of Vermont

elias.klemperer@med.uvm.edu

802-656-1641

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 1, 2021
• Study Start: June 27, 2021
• Primary Completion: August 2, 2023
• Study Completion: October 25, 2023
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-04

Locations

US (1)