- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04951193
Goal2QuitVaping for Nicotine Vaping Cessation Among Adolescents
July 21, 2023 updated by: Jennifer Dahne, Medical University of South Carolina
Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients
The purpose of this study is to evaluate a mobile application (app) called "Goal2QuitVaping" to help adolescents quit vaping nicotine.
Goal2QuitVaping was developed by our research team to assist with quitting vaping.
Participants will be randomly assigned to either download the mobile app, "Goal2QuitVaping", or not.
If provided with Goal2QuitVaping, participants will be asked to use the app regularly, at least once per day, throughout the study duration.
Participants will be asked to complete electronic questionnaire measures throughout the study period.
Participation in this study will take about 4 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Dahne, PhD
- Phone Number: 843-876-2280
- Email: dahne@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age 16-20
- vaped nicotine on ≥20 days out of the last 30
- elevated depressive symptoms, defined as a score of ≥10 on Patient Health Questionnaire-8 (PHQ-8) during preliminary screening and the Adolescent Patient Health Questionnaire-9 (PHQ-9A) at final eligibility
- currently own an iOS or Android smartphone
- report willingness to utilize an app for quitting vaping nicotine (response of "yes" on yes/no item)
- have a valid e-mail address that is checked regularly or regular access to text messages (for follow-up assessments)
- ability to read the consent form
- has been seen (in person or remotely) by a primary care physician within the last year
Exclusion Criteria:
- smoked cigarettes or used other tobacco products on ≥9 days out of the last 30
- severe visual impairment
- currently receiving treatment for vaping or tobacco use
- current suicidal ideation, defined as a response ≥1 on item nine of the PHQ-9A or ≥2 on item 9 of the BDI-II
- household member currently enrolled in the study
- inability to read the consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Goal2QuitVaping
Participants in the Goal2QuitVaping group will be asked to download the Goal2QuitVaping app to their smartphone.
Goal2QuitVaping focuses on mood management as well as on quitting vaping nicotine.
Participants will be asked to use Goal2QuitVaping regularly, at least once per day, for the study duration.
Participants will also be asked to complete questionnaires weekly for 4 weeks.
|
Goal2QuitVaping focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood.
Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
|
Other: Treatment as Usual
Participants in the treatment as usual group will be provided with educational material about quitting vaping nicotine and it will be suggested that they discuss any questions about mood management and about quitting vaping with their primary care provider.
The educational material is from the National Cancer Institute's SmokeFree Teen website and includes information on recognizing reasons for quitting vaping, avoiding dual use of e-cigarettes and other tobacco products, setting a quit date, understanding triggers, and accessing social support.
|
Participants will be provided educational material about quitting vaping nicotine with the suggestion to discuss questions with their PCP.
Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean score of depressive symptoms
Time Frame: Up to 4 weeks
|
Patients will self report depressive symptoms weekly for 4 weeks via the Beck Depression Inventory-II.
The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.
|
Up to 4 weeks
|
E-cigarette use episodes per day and per week
Time Frame: Up to 4 weeks
|
Assessed using the Timeline Followback at baseline for the last 6 months and during each weekly assessment.
|
Up to 4 weeks
|
E-cigarette dependence
Time Frame: Up to 4 weeks
|
Assessed at baseline via the 10-item Penn State Electronic Cigarette Dependence Index (ECDI)
|
Up to 4 weeks
|
Number/duration of quit attempts
Time Frame: Up to 4 weeks
|
Assessed during the Timeline Followback
|
Up to 4 weeks
|
7-day point prevalence abstinence
Time Frame: Week 4
|
Assessed during the Timeline Followback
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Dahne, PhD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
May 24, 2023
Study Completion (Actual)
June 21, 2023
Study Registration Dates
First Submitted
June 25, 2021
First Submitted That Met QC Criteria
July 2, 2021
First Posted (Actual)
July 6, 2021
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00108733
- 1R41DA053856-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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