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

The University of Chicago

Status: Enrolling

Conditions: Cigarette Smoking; Tobacco Products; Electronic Nicotine Delivery Systems

Treatments: Behavioral: Standard Care; Behavioral: EQUIP

Study type: Interventional

Funder types: Other

Identifiers

NCT06395415

IRB21-1839

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

mobile health (mHealth)

Experimental group

Description:

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.

Treatment:

Behavioral: EQUIP

Standard care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Care