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Smoke-Free Policy Support for Smoking Cessation

N/A
Recruiting
Led By Diana Hernández, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Building
Additional eligibility criteria include individuals above 18 years old living in the building at least 5 days/week and 9 months/year, not planning on moving in the next 2 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Awards & highlights

Study Summary

This trial will test two ways to reduce exposure to secondhand smoke in residential buildings. One targets all building residents, while the other targets smokers specifically, with the goal of reducing smoking and exposure to secondhand smoke.

Who is the study for?
This trial is for adults over 18 living in certain NYCHA buildings in Manhattan and the Bronx, who are there at least 5 days a week and not moving within two years. Smokers and non-smokers can join but must not have severe health issues that affect consent or participation.Check my eligibility
What is being tested?
The study tests two strategies to cut down secondhand smoke: one encourages all residents to support smoke-free policies (resident endorsement), while the other helps smokers reduce or quit smoking by changing where they smoke.See study design
What are the potential side effects?
Since this trial involves behavioral interventions like policy endorsement and smoking reduction rather than medication, it does not have typical medical side effects. However, participants may experience stress or discomfort from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I'm sorry, but this is not a clinical trial exclusion criterion. Can you please provide me with the correct criterion so I can rewrite it for you?
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I am over 18, live in the building most of the year, and won't move for 2 years.
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I am either a smoker or a non-smoker living in an apartment.
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I have smoked at least 5 days in the past month or quit smoking more than a year ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in number of cigarettes smoked per day
Change in salivary cotinine
Change in secondhand smoke exposure
Secondary outcome measures
Change in number of cigarette butts
Change in number of hours of secondhand smoke exposure
Change in number of participants with secondhand smoke observations
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Compliance through resident endorsementExperimental Treatment1 Intervention
Buildings assigned will be targeted for a series of 2 in-residence programs that involve community forums and the creative arts to garner resident endorsements of smoke-free living environments. Premised on resident engagement, this arm seeks to impact social and physical dimensions of the residential environment to achieve compliance. The sessions will: 1) inform residents of risks associated with smoking and secondhand smoke; 2) identify reasons to have a smoke-free home, 3) ask residents to sign a pledge on paper and/or virtually; 4) display smoke-free signage on doors and/or social media pages with an original hashtag (#Smokefree[building address]); and 5) refer residents to the Smoke-free NYCHA website for information on the policy and existing cessation resources.
Group II: Compliance through reduction/cessation plus resident endorsement (combined)Experimental Treatment2 Interventions
The combined intervention will be carried out in the buildings assigned to this RCT arm, which will provide in-residence programs based on the resident endorsement treatment and the smoking relocation/cessation treatment. Both will occur simultaneously with one geared toward all building residents (resident endorsement) and the other targeting smokers (smoking relocation/cessation) with the goal of reducing both personal smoking and secondhand smoke exposure.
Group III: Compliance through reduction (relocation and reduction of personal smoking) and cessationExperimental Treatment1 Intervention
Smokers will be referred by the survey team to peer educators from a community-based organization trained to provide peer to peer health education including tobacco cessation support. The peer educator will coordinate smoking cessation support, including serving as a liaison between participant and research team, providing information regarding the smoke-free policy and opportunities for relocation, and connecting participant to access to tobacco replacement therapy and/or physician support if deemed appropriate.
Group IV: Standard NYCHA approach (control)Active Control1 Intervention
Buildings and study participants assigned to this arm will be recruited and followed over a 12-month period to assess outcomes. No additional programs or services will be delivered to the buildings or residents assigned to this arm beyond standard programs that NYCHA may provide to support the smoke-free mandate. Field staff will document any policy-related signage, activities or information to which these participants are exposed.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,296 Total Patients Enrolled
4 Trials studying Smoking
12,318 Patients Enrolled for Smoking
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,883 Total Patients Enrolled
63 Trials studying Smoking
53,591 Patients Enrolled for Smoking
Diana Hernández, PhDPrincipal InvestigatorAssociate Professor

Media Library

Reduction (relocation and reduction of personal smoking) and cessation Clinical Trial Eligibility Overview. Trial Name: NCT05016505 — N/A
Smoking Research Study Groups: Compliance through resident endorsement, Compliance through reduction/cessation plus resident endorsement (combined), Standard NYCHA approach (control), Compliance through reduction (relocation and reduction of personal smoking) and cessation
Smoking Clinical Trial 2023: Reduction (relocation and reduction of personal smoking) and cessation Highlights & Side Effects. Trial Name: NCT05016505 — N/A
Reduction (relocation and reduction of personal smoking) and cessation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016505 — N/A
Smoking Patient Testimony for trial: Trial Name: NCT05016505 — N/A

Frequently Asked Questions

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

How many study subjects are you working with in total?

"That is correct, the online information does show that the study is recruiting patients. The clinical trial was first advertised on February 3rd, and there have been recent updates on February 18th. A total of 512 patients are needed for the study, which is only enrolling at a single site."

Answered by AI

What are the researchers ultimately hoping to achieve with this trial?

"The key metric that this trial is measuring is change in salivary cotinine levels, which will be reported at the start of the study, 3 months in, and 12 months after the study has concluded. Additionally, the trial will also measure the number of successful quit attempts, the number of smokers, and the number of hours of secondhand smoke exposure."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
New York
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m just curious with studies and would love to learn more. I'm interested in study and would like to be a part of it. I feel knowing the a.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is screening visits ? Is it a pay study?
PatientReceived 2+ prior treatments
Recent research and studies
~71 spots leftby Aug 2024