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Smoking Cessation E-Visit for Quitting Smoking (INSPIRE 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 will evaluate an online questionnaire to help people quit smoking, with potential to receive a prescription for a smoking cessation medication. Participants will complete questionnaires & provide breath samples over a 24 week period.
Who is the study for?
This trial is for adults who smoke at least 5 cigarettes daily, have been smoking regularly for over 6 months, and are not currently using any quit-smoking treatments. Participants must live where they can get mail, speak English, use or be willing to sign up for Epic's MyChart program, check their email daily, and own a smartphone compatible with the study's breath sample app.
What is being tested?
The study is testing an online e-visit system designed to help people stop smoking in rural primary care settings. Some participants will receive this e-visit intervention while others will continue with usual care. The e-visit includes questions about smoking habits and may lead to a prescription for quitting aids but doesn't require taking medication.
What are the potential side effects?
There might be no direct side effects from participating in the e-visits themselves; however, if participants choose to take prescribed cessation medications as a result of the e-visit recommendation, they could experience side effects associated with those specific drugs.
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
Reduction in Cigarettes Per Day
Smoking Cessation
Awards & 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
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
972 Previous Clinical Trials
7,399,014 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,713 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have started a smoking cessation treatment with FDA-approved medication in the last week.I have been smoking more than 5 cigarettes daily for the last 6 months.I am 18 years old or older.I am enrolled in or willing to enroll in Epic's MyChart program.I check my email daily and can access study materials and messages.
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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