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

NCT06395415 | Recruiting

• 1 other identifier: IRB21-1839
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

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

Secondary Outcomes (1)

• ENDS use

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

Study Arms (2)

mobile health (mHealth)

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

EQUIP BEHAVIORAL

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.

mobile health (mHealth)

Standard Care BEHAVIORAL

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.

Standard care

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago BREATHE Laboratory

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Cigarette Smoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Emma Brett, PhD

CONTACT

773-834-5341; ebrett@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 2, 2024
• Study Start: April 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-01

Locations

US (1)