Recruiting

mHealth Intervention

Sponsor:

University of Chicago

Code:

NCT06395415

Conditions

Electronic Nicotine Delivery Systems

Tobacco Products

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Accepted

Interventions

EQUIP

Standard Care

Study Details

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.

Conditions

Electronic Nicotine Delivery Systems

Tobacco Products

Cigarette Smoking

Study ID

NCT06395415

Start date

Apr 25, 2025

Status verified date

Jan, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 26

Healthy Volunteers: Accepted

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

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

EQUIP

The intervention is delivered directly to participants' mobile phones using the Insight® platform, which allows for the implementation of assessments and interventions. Insight has been used in prior mHealth studies and allows for the delivery of tailored content based on parameters, such as intervention stage. The intervention has two stages: 1) Motivational enhancement (weeks 1-2) and 2) Skills and information (weeks 3-6). The first stage of messages will utilize personalized feedback and motivational interviewing prompts, while the second stage will provide health information on ENDS and skills, such as deep breathing. Content is tailored to motivation level (low/medium or high) and dual use status.

Standard Care

Those in the standard advice group will be given offered a sample of NRT, instruction on its use, and will be encouraged to use in conjunction with standard web-based resources on ENDS and cessation over the course of a ten minute walk-through with study staff.

Primary outcome measure

  • ENDS cessation [ Time Frame: post-treatment (6 weeks) and at 6-week follow-up (week 12). ]

Central Contacts and Locations

Central contacts

Locations

University of Chicago BREATHE Laboratory

Recruiting

Chicago, Illinois, United States, 60637

Contacts

More Information

Sponsor

University of Chicago

Last update posted

Apr 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-27.