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Recruiting NCT06395415

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

No phase Interventional Electronic Nicotine Delivery Systems Tobacco Products Cigarette Smoking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EQUIP, Standard Care.
Who it may be relevant to
Registry conditions: Electronic Nicotine Delivery Systems, Tobacco Products, Cigarette Smoking. Basic parameters: 18 years — 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral 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 moti
  • Behavioral 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 measures

  • ENDS cessation [Time frame: post-treatment (6 weeks) and at 6-week follow-up (week 12).]
Secondary outcome measures (1)
  • ENDS use [Time frame: post-treatment (6 weeks) and at 6-week follow-up (week 12).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Chicago BREATHE Laboratory — Chicago

Identifiers

NCT: NCT06395415 · IRB21-1839

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗