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Behavioral Intervention
Smartphone-Based Program for Vaping Cessation
N/A
Waitlist Available
Led By Jennifer Marler, MD
Research Sponsored by Pivot Health Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year (52 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a vaping cessation program can help people quit smoking.
Who is the study for?
This trial is for daily nicotine vape users in the U.S. who plan to quit within 30 days, can read English, and are willing to use a smartphone app (iPhone 5/iOS 12 or Android 7.0+) with internet access for cessation coaching. Ex-smokers must have quit over 3 months ago and participants cannot be using other vaping cessation programs.
What is being tested?
The study tests the 'Pivot for Vape' program's effectiveness in helping people stop vaping. It's an open label pilot study enrolling up to 100 participants who will receive support through a smartphone-based cessation program.
What are the potential side effects?
Since this trial involves a behavioral intervention via a smartphone app rather than medication, traditional side effects like those seen with drugs are not expected; however, participants may experience stress or frustration during the quitting process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year (52 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year (52 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Vaping cessation rate: 30-day PPA
Secondary study objectives
Alcohol use behavior
Average number of weeks with coach engagement
Change in confidence levels toward quitting vaping (expected success in quitting)
+30 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pivot for VapeExperimental Treatment1 Intervention
A commercially available mobile phone app and program for vaping cessation
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Who is running the clinical trial?
Pivot Health Technologies Inc.Lead Sponsor
3 Previous Clinical Trials
419 Total Patients Enrolled
Jennifer Marler, MDPrincipal InvestigatorPivot Health Technologies Inc.
4 Previous Clinical Trials
303 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to quit vaping within the next 6 months.I am not using any other vaping cessation programs.You have been using nicotine vape/e-cigarettes every day for the past 30 days.I quit smoking more than 3 months ago.You intend to stop using e-cigarettes within the next month.I am willing to work with a quit vaping coach through text messages.You feel at ease with downloading and using apps on your smartphone.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pivot for Vape
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.