ClinicalTrials.gg
RecruitingNCT06395415EQUIPUpdated Apr 27, 2026

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

An interventional study of EQUIP and Standard Care in Electronic Nicotine Delivery Systems, Tobacco Products and Cigarette Smoking, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by University of Chicago · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 26 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Electronic Nicotine Delivery Systems
  • Tobacco Products
  • Cigarette Smoking
03

In context

Vaping

402 studies on the registry are indexed under Vaping; 95 are open to participants now.

This study's planned enrollment of 46 is below the median of 79 across 322 interventional studies indexed under Vaping.

Browse Vaping studies →

Lead sponsor

University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18-26 years old, ability to understand the English language, willing and able to provide
  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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study 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.

    Behavioral: EQUIP

  • 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.

    Behavioral: Standard Care

Interventions

  • BehavioralEQUIP

    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.

  • BehavioralStandard 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.

06

What researchers measure

Primary outcomes

  1. ENDS cessation

    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.

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

Secondary outcomes

  1. ENDS use

    Frequency of ENDS use as determined by Timeline Followback Interview with study staff will be measured as a secondary outcome.

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

07

Study locations

1 of 1 sites recruiting
  • University of Chicago BREATHE Laboratory
    Chicago, Illinois 60637, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Interested parties can contact the PI for access to deidentified participant data. Requests will be granted as appropriate.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06395415
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Apr 25, 2025
Primary completion
Jul 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Apr 27, 2026

Study contacts

Emma Brett, PhD
Contact
ebrett@bsd.uchicago.edu
773-834-5341

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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