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

Cigarette Smoking Clinical Trial

— EQUIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395415
• Other study ID #: IRB21-1839
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: Emma Brett, PhD
• Phone: 773-834-5341
• Email: ebrett[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Tobacco Products

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ENDS use	Frequency of ENDS use as determined by Timeline Followback Interview with study staff will be measured as a secondary outcome.	post-treatment (6 weeks) and at 6-week follow-up (week 12).