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Smoke-Free Homes Intervention for Smoking Cessation (SFH 5A RCT Trial)
N/A
Waitlist Available
Led By Michelle Kegler, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
adults unable to consent
18 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months,12 months
Awards & highlights
SFH 5A RCT Trial Summary
This trial will test whether adding an intervention to create smoking bans in homes and vehicles to existing clinical guidelines for quitting smoking will help low-income patients sustain quitting smoking.
Who is the study for?
This trial is for adult smokers referred by a primary care physician from a participating health center in South Georgia, who have smoked recently but aren't in another cessation program. Participants must speak and understand English, be the only person from their household to join, and not be pregnant or unable to consent.Check my eligibility
What is being tested?
The study tests if adding a smoke-free homes intervention into tobacco quitting guidelines helps people stop smoking. It includes three mailings and two coaching calls aimed at creating no-smoking rules at home and in cars.See study design
What are the potential side effects?
Since this trial involves behavioral interventions like coaching calls and educational materials rather than medications, it does not have typical medical side effects. However, participants may experience stress or frustration while trying to quit smoking.
SFH 5A RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am unable to give consent for medical procedures.
Select...
I am 18 years old or older.
Select...
I cannot clearly understand English.
Select...
I have difficulty making decisions due to cognitive impairment.
SFH 5A RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months,12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months,12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who achieved smoking cessation/abstinence
Secondary outcome measures
Change in number of cigarettes smoked in the home
Change in number of cigarettes smoked per day on smoking days
Duration of abstinence (i.e. days since last use) at 12-month follow up
+6 moreSide effects data
From 2012 Phase 4 trial • 200 Patients • NCT0134251030%
Pain with injection of propofol
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine/Magnesium
Control
Lidocaine
Magnesium
SFH 5A RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Smoke-Free Homes InterventionExperimental Treatment2 Interventions
Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
Group II: ControlActive Control1 Intervention
The usual care/control arm will receive mailed information on the quitline and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,559,421 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,909,338 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,914,302 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is no specific criterion provided. Please provide more context or information to help me better understand what you mean by "community participation".You are pregnant.You have smoked a cigarette within the last 30 days.I am unable to give consent for medical procedures.You do not smoke cigarettes.I am 18 years old or older.I am younger than 18 years old.I cannot clearly understand English.I have difficulty making decisions due to cognitive impairment.You are currently in prison.You do not understand or speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Smoke-Free Homes Intervention
- Group 2: Control
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative currently available to participants?
"Clinicaltrials.gov provides evidence that this medical study, initially published on November 11th 2020 and last amended on July 26th 2022, is no longer searching for participants. Luckily though, 142 other clinical trials are currently recruiting patients at the moment."
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