NCT05906082

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
May 2023Dec 2026

Study Start

First participant enrolled

May 25, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

3.6 years

First QC Date

May 26, 2023

Last Update Submit

August 3, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Number of participants recruited and randomized

    Number of participants recruited and randomized

    Throughout 12 months

  • Self-reported proportion of text messages read

    Proportion of text messages read during the intervention or standard care at 1 month

    At 1 month

  • 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

  • Level of acceptability of the intervention

    1. 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) 2. 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) 3. 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) 4. 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) 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

  • Proportion of salivary cotinine samples returned

    Proportion of salivary cotinine samples returned to the office lab for cotinine analysis

    At 1 month

  • 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

  • Concentration of cotinine in saliva

    Biochemically verified abstinence evaluated by salivary cotinine samples

    At 1 month

  • Nicotine dependence (Penn State Electronic Cigarette Dependence Index)

    Nicotine dependence (minimum 0 to maximum 20, higher scores mean a worse outcome.)

    At 1 month

Study Arms (2)

Intervention (E-cigarette cessation text-messaging intervention)

EXPERIMENTAL
Behavioral: E-cigarette cessation text-messaging intervention

Standard care (Standard care control using standard national resources)

ACTIVE COMPARATOR

This standard care group will receive standard care resources from smokefree.gov.

Behavioral: Standard care control using standard national resources

Interventions

This is the intervention for e-cigarette cessation using text messages targeting young adults in rural areas.

Intervention (E-cigarette cessation text-messaging intervention)

This is the standard care with national resources from smokefree.gov.

Standard care (Standard care control using standard national resources)

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 15, 2023

Study Start

May 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations