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A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults

Primary Purpose

Nicotine Dependence, Nicotine Addiction, Nicotine Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone app
Text Message
Survey Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nicotine Dependence

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18-30. Current weekly user of e-cigarette product(s). Owns an Android phone or iPhone. Has an email address. United States (US) resident, with a US mailing address. Willing to complete all study procedures. Exclusion Criteria: Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation). Member of the same household as another research participant.

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (Act on Vaping app)

Arm II (Incentivized text message check-ins)

Arm Description

Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.

Participants receive incentivized text messages check-ins assessing their vaping status.

Outcomes

Primary Outcome Measures

Overall treatment satisfaction rating
Will calculate descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to assess treatment satisfaction (i.e., mean level of overall satisfaction with ACT on Vaping, with 3.5 on a 5-point scale being the "go" criterion).
Change in readiness to quit
Will evaluate differences of Contemplation Ladder scores.
Self-reported 24-hour quit attempt
Will evaluate differences descriptively.
Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco
Will evaluate differences descriptively.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2023
Last Updated
May 31, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05897242
Brief Title
A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults
Official Title
ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called ACT on Vaping.
Detailed Description
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status. ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Nicotine Addiction, Nicotine Use Disorder, Nicotine Vaping, Vaping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Any outcome evaluator who has direct contact with participants will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Act on Vaping app)
Arm Type
Experimental
Arm Description
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Arm Title
Arm II (Incentivized text message check-ins)
Arm Type
Active Comparator
Arm Description
Participants receive incentivized text messages check-ins assessing their vaping status.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone app
Other Intervention Name(s)
ACT on Vaping
Intervention Description
Use ACT on Vaping smartphone app
Intervention Type
Other
Intervention Name(s)
Text Message
Other Intervention Name(s)
SMS Text
Intervention Description
Receive text messages
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Overall treatment satisfaction rating
Description
Will calculate descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to assess treatment satisfaction (i.e., mean level of overall satisfaction with ACT on Vaping, with 3.5 on a 5-point scale being the "go" criterion).
Time Frame
At 3 months
Title
Change in readiness to quit
Description
Will evaluate differences of Contemplation Ladder scores.
Time Frame
From baseline to 3 months post-randomization
Title
Self-reported 24-hour quit attempt
Description
Will evaluate differences descriptively.
Time Frame
At 3 months post-randomization
Title
Cotinine-confirmed 30-day point prevalence abstinence from all nicotine and tobacco
Description
Will evaluate differences descriptively.
Time Frame
At 3 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-30. Current weekly user of e-cigarette product(s). Owns an Android phone or iPhone. Has an email address. United States (US) resident, with a US mailing address. Willing to complete all study procedures. Exclusion Criteria: Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation). Member of the same household as another research participant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaimee Heffner
Phone
206-667-7314
Email
jheffner@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimee Heffner
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaimee Heffner
Phone
206-667-7314
Email
jheffner@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Jaimee Heffner

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults

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