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Telehealth Smoking Cessation for Quitting Smoking (E-STOP Trial)
N/A
Recruiting
Research Sponsored by Medical University of South Carolina
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 month 6
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether an electronic visit (e-visit) for smoking cessation is effective. Participants will be assigned at random to either receive the e-visit or not. The e-visit will be in the form of an online questionnaire about smoking history, motivation to quit, and preferences for quitting medications. If participants are randomized to the e-visit group, they may receive a prescription for a smoking cessation medication, but they are not required to take it. The study will last 24 weeks and consist of four time points where participants will answer questionnaires and provide breath samples.
Who is the study for?
This trial is for adults who smoke at least 5 cigarettes a day, are fluent in English, have daily email access, and own a smartphone. They must be enrolled or willing to enroll in MyChart with a valid address. It's not for those who've used FDA-approved quitting meds recently.
What is being tested?
The study tests an e-visit system designed to help people quit smoking against the usual treatment methods. Participants will either receive this innovative online support tool or continue with standard care without the e-visit intervention.
What are the potential side effects?
Since participants may get prescriptions for smoking cessation medications based on their e-visits, potential side effects include those associated with such medications like nausea, insomnia, headaches, dry mouth, and constipation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cigarettes smoking
E-visit Acceptability
E-visit Adoption
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Smoking cessation electronic visit (e-visit)Experimental Treatment1 Intervention
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.
Group II: Treatment as usual (TAU)Active Control1 Intervention
This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoking cessation e-visit
2019
N/A
~60
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,329 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
972 Previous Clinical Trials
7,398,630 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I check my email daily with a valid email address.You need to have an iOS or Android smartphone to participate in the study and provide remote carbon monoxide readings.I have used a quit-smoking medication approved by the FDA in the past week.I am 18 years old or older.I am enrolled in MyChart or willing to sign up.You have been smoking 5 or more cigarettes per day for at least 6 months out of the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Smoking cessation electronic visit (e-visit)
- Group 2: Treatment as usual (TAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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