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Clinical Trials/NCT06395415
NCT06395415
Recruiting
Not Applicable

Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults

University of Chicago1 site in 1 country46 target enrollmentApril 25, 2025

Overview

Phase
Not Applicable
Intervention
EQUIP
Conditions
Electronic Nicotine Delivery Systems
Sponsor
University of Chicago
Enrollment
46
Locations
1
Primary Endpoint
ENDS cessation
Status
Recruiting
Last Updated
5 days ago

Overview

Brief Summary

Electronic Nicotine Delivery Systems (ENDS) use remains prevalent among young adults, and many have high interest in quitting, yet research on effective intervention is lacking. A mobile health (mHealth) intervention that translates effective smoking cessation materials and pharmacotherapy may be a promising avenue for intervention. The initial phase of the proposed study uses a pilot study to evaluate a novel mHealth intervention for young adult ENDS and dual product (ENDS and combustible cigarette) users.

Registry
clinicaltrials.gov
Start Date
April 25, 2025
End Date
August 1, 2026
Last Updated
5 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-26 years old, ability to understand the English language, willing and able to provide informed consent
  • Current ENDS user (at least 4 out of 7 days per week of use for the past one month); for focus groups, at least half of participants will report current cigarette smoking (at least 1 cigarette per day on at least 1 day per week in the past month)
  • Report interest in quitting or reducing ENDS (at least 6/10 scale in interest of quitting or reducing
  • Does not currently (in past one year) meet criteria for major psychiatric disorder including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
  • For women, not currently pregnant, planning to become pregnant, or breastfeeding due to lack of information on ENDS use and possible harms from NRT during pregnancy
  • Not currently using smoking cessation medication (i.e., Varenicline, Bupropion
  • No history of adverse reactions to nicotine replacement therapy

Exclusion Criteria

  • Does not own a mobile phone or is unwilling to receive text messages to their device
  • No interest in quitting or reducing use of ENDS
  • Uses electronic cigarettes less than 4 days per week in the past month
  • Reports past-year serious psychiatric illness, including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder
  • Is currently using smoking cessation medication including Varenicline or Bupropion
  • Are a female who is currently pregnant or nursing or planning to become pregnant within the next 6 months

Arms & Interventions

mobile health (mHealth)

Participants in this arm will receive a 6-week mHealth message based intervention through their smartphone. They will also have the option of requesting free nicotine replacement therapy (NRT) throughout the treatment period.

Intervention: EQUIP

Standard care

Participants in this arm will receive a 5-10 minute walk-through of electronic nicotine delivery system (ENDS) and tobacco education and skills based on the most recent evidence. They will also have the options of requesting a sample of NRT.

Intervention: Standard Care

Outcomes

Primary Outcomes

ENDS cessation

Time Frame: post-treatment (6 weeks) and at 6-week follow-up (week 12).

ENDS cessation will be measured using a modified Timeline Followback Interview using 7-day point prevalence abstinence with study staff and then confirmed via a mailed saliva cotinine test.

Secondary Outcomes

  • ENDS use(post-treatment (6 weeks) and at 6-week follow-up (week 12).)

Study Sites (1)

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