Vape-Free Text-Messaging: Pilot Study

E-cigarette Use Clinical Trial

Official title:

Text-messaging E-cigarette Cessation Intervention for Young Adults in Rural Areas: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906082
• Other study ID #: 23.179
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a small pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of the e-cigarette cessation text-messaging intervention with young adults in rural areas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• English speaking
• 18-24 years
• everyday e-cigarette use in the past month
• ownership of a mobile phone or smartphone with texting and internet access abilities
• knowledge of how to use text messages
• plan on quitting e-cigarette use within one month
• home address in a rural county of Wisconsin, Minnesota, North Dakota, and South Dakota

Exclusion Criteria:

• Individuals who reported use of other tobacco products (e.g., cigarettes, smokeless tobacco) than e-cigarettes in the past month

Related Conditions & MeSH terms

• E-cigarette Use

Intervention

Behavioral:
• E-cigarette cessation text-messaging intervention
This is the intervention for e-cigarette cessation using text messages targeting young adults in rural areas.
• Standard care control using standard national resources
This is the standard care with national resources from smokefree.gov.

Locations

Country	Name	City	State
United States	University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Seok Hyun Gwon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited and randomized	Number of participants recruited and randomized	Throughout 12 months
Primary	Self-reported proportion of text messages read	Proportion of text messages read during the intervention or standard care at 1 month	At 1 month
Primary	Retention rates (proportion of participants remained until 1 month post-intervention from enrollment)	Proportion of participants from enrollment to 1 month post-intervention or standard-care	At 1 month
Primary	Level of acceptability of the intervention	When you had received our text messages from our VapeFreeTXT program 1 month ago, how many of our text messages did you read on a typical day? Not at all (1) Read about 25% messages (2) Read about half messages (3) Read about 75% messages (4) Read the entire messages (5); How useful was our VapeFreeTXT program in helping you quit vaping? Not at all useful (1) Slightly useful (2) Moderately useful (3) Very useful (4) Extremely useful (5); Did our VapeFreeTXT program make you think about quitting vaping? Not at all (1) Probably not (2) Neither yes nor no (3) Probably yes (4) Definitely yes (5); Do you think our VapeFreeTXT program will change your vaping? Not at all (1) Probably not (2) Neither yes nor no (3) Probably yes (4) Definitely yes (5); Would you recommend this program to a friend or others? Not at all (1) Probably not (2) Neither yes nor no (3) Probably yes (4) Definitely yes (5)	At 1 month
Primary	Proportion of salivary cotinine samples returned	Proportion of salivary cotinine samples returned to the office lab for cotinine analysis	At 1 month
Primary	Self-reported 7-days point prevalence abstinence from ENDS and other tobacco	Self-reported 7-days point prevalence abstinence from ENDS and other tobacco	At 1 month
Primary	Concentration of cotinine in saliva	Biochemically verified abstinence evaluated by salivary cotinine samples	At 1 month
Primary	Nicotine dependence (Penn State Electronic Cigarette Dependence Index)	Nicotine dependence (minimum 0 to maximum 20, higher scores mean a worse outcome.)	At 1 month