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Digital Coaching for Electronic Cigarette Use ((RISE) Trial)

Phase 4
Recruiting
Led By Liz Klein, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current, regular user of nicotine e-cigarettes (20+ days in the last month)
Exclusive e-cigarette user (no other tobacco in the last 30 days; or no other tobacco in the last 90 days if smoked 100+ cigarettes or cigarillos in lifetime)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 3 months after study enrollment
Awards & highlights

(RISE) Trial Summary

This trial will test different components to help young adults quit vaping. All participants will receive quitline-delivered behavioral phone counseling, and components being tested are a digital intervention (with text and online cessation support) and nicotine replacement therapy (NRT).

Eligible Conditions
  • Electronic Cigarette Use
  • Nicotine Addiction

(RISE) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have used e-cigarettes with nicotine regularly for at least 20 days in the past month.
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You only use e-cigarettes and haven't used any other tobacco products in the last 30 days. If you have smoked 100 or more cigarettes or cigarillos in your lifetime, you must not have used any other tobacco products in the last 90 days.
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You have a smartphone.
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You are willing to try to quit within the next month.

(RISE) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 3 months after study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 3 months after study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
7-day point prevalence vaping abstinence
Secondary outcome measures
Changes in e-cigarette use frequency
E-cigarette dependence - PROMIS-E
E-cigarette dependence - Penn State E-cigarette Dependence Questionnaire
+1 more

(RISE) Trial Design

4Treatment groups
Experimental Treatment
Group I: DigitalNRTArmExperimental Treatment3 Interventions
This arm will receive digital content (text messages with links to online materials) AND Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Group II: DigitalArmExperimental Treatment2 Interventions
Phone Coaching + Digital Coaching; no NRT: This arm will receive digital content (text messages with links to online materials) in addition to to the two phone counseling calls which all arms will receive.
Group III: CoachingOnlyArmExperimental Treatment1 Intervention
Phone Coaching; no Digital Coaching, no NRT: This arm will receive only the two phone counseling calls which all other arms will receive.
Group IV: CoachingNRTArmExperimental Treatment2 Interventions
Phone Coaching + NRT; no Digital Coaching: This arm will receive Nicotine Replacement Therapy (NRT) in addition to the two phone counseling calls which all arms will receive.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Phone Counseling
2008
Completed Early Phase 1
~930

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
821 Previous Clinical Trials
500,622 Total Patients Enrolled
American Heart AssociationOTHER
319 Previous Clinical Trials
4,931,909 Total Patients Enrolled
Optum, Inc.Industry Sponsor
9 Previous Clinical Trials
1,348,571 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved Digital Coaching as a legitimate therapeutic solution?

"Due to being in Phase 4 trials, Digital Coaching's safety score is 3, indicating that it has been approved."

Answered by AI

Could you provide a figure for how many people have participated in the research so far?

"Affirmative. ClinicalTrials.gov data indicates that this medical research is presently recruiting patients, with the first posting having gone live on July 5th 2021 and a subsequent update occurring on October 3rd 2022. A total of 513 participants are sought out at one facility."

Answered by AI

Is there an upper age limitation for participation in this experiment?

"According to the terms of this trial, participants must range in age between 18 and 24 years old."

Answered by AI

To what extent has Digital Coaching been explored in prior clinical research?

"Presently, 71 Digital Coaching studies are underway and 5 of them have reached Phase 3. Most trials for this particular treatment are located in Green Bay, Wisconsin yet there is a total of 204 sites that offer the therapy."

Answered by AI

Am I a suitable candidate for enrollment in this experiment?

"Participants of this trial need to be between the ages 18-24, and display a history of tobacco dependence. Altogether 513 individuals can enroll in this clinical study."

Answered by AI

Are there currently any openings to participate in this trial?

"Affirmative. Clinicaltrials.gov corroborates that the study is still recruiting, with the first post dated July 5th 2021 and last update on October 3rd 2022. The experiment necessitates 513 subjects from one medical facility."

Answered by AI
~140 spots leftby Mar 2025