Clinical trial NCT06395415: Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults
Official title: Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Electronic Nicotine Delivery Systems
Tobacco Products
Cigarette Smoking
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ENDS cessation
timeFrame: post-treatment (6 weeks) and at 6-week follow-up (week 12).
Secondary outcomes:
measure: ENDS use
timeFrame: post-treatment (6 weeks) and at 6-week follow-up (week 12).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago BREATHE Laboratory
state: Illinois
Study officials:
References: