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

Not Applicable

Recruiting

• Conditions: Electronic Nicotine Delivery Systems; Tobacco Products; Cigarette Smoking

• Registration Number: NCT06395415
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-05-02
• Study Start: 2025-04-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-11-11
• Last Update Posted: 2025-11-12
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age 18-26 years old, ability to understand the English language, willing and able to provide informed consent, 2) 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), 3) Report interest in quitting or reducing ENDS (at least 6/10 scale in interest of quitting or reducing, 4) 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, 5) 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, 6) Not currently using smoking cessation medication (i.e., Varenicline, Bupropion, 7) No history of adverse reactions to nicotine replacement therapy.

Exclusion Criteria

1. Does not own a mobile phone or is unwilling to receive text messages to their device, 2) No interest in quitting or reducing use of ENDS, 3) Uses electronic cigarettes less than 4 days per week in the past month, 4) Reports past-year serious psychiatric illness, including severe alcohol or substance use disorder (excluding tobacco use disorder), schizophrenia, bipolar disorder, and obsessive compulsive disorder, 5) Is currently using smoking cessation medication including Varenicline or Bupropion, 6) Are a female who is currently pregnant or nursing or planning to become pregnant within the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ENDS cessation	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 Outcome Measures

Name	Time	Method
ENDS use	post-treatment (6 weeks) and at 6-week follow-up (week 12).	Frequency of ENDS use as determined by Timeline Followback Interview with study staff will be measured as a secondary outcome.

Trial Locations

Locations (1)

University of Chicago BREATHE Laboratory; 🇺🇸 Chicago, Illinois, United States