MedTrace Logo

Quit Smoking Study for People Who Use E-Cigarettes

NCT04946825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2025-05-22

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Nicotine replacement therapy patch

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.

DRUG

Nicotine replacement therapy lozenge

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.

BEHAVIORAL

Quit electronic cigarettes

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

BEHAVIORAL

Continue electronic cigarettes

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

Sponsors & Collaborators

  • University of Vermont

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-27
Primary Completion
2023-08-02
Completion
2023-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04946825 on ClinicalTrials.gov