Tobacco Cessation in Public Housing

January 5, 2026 updated by: Johns Hopkins University

Comprehensive Tobacco Cessation for Residents of Baltimore City Public Housing

The inequity in cessation resources is at forefront in the recently enacted nationwide smoking ban in public housing facilities. The critical component lacking from the federal decree was a practical smoking cessation strategy to address the real-world needs of active smokers who maintain cigarette usage. The investigator's proposal is ideally situated for this contemporary moment when low-income smokers in public housing are signing leases describing the potential for smoking-related evictions and thus at least contemplating smoking modification. The investigator's project is centered around the residents of Baltimore City Public Housing which is among the larger-sized U.S. public housing agencies. Using a human-centered design (HCD) approach, the investigators are refining and testing a community-centric cessation strategy defined by two core elements: a) durable and jointly linked community/hospital infrastructure systems (remote cessation specialist staffing and drug supplies) and strong on-site (public housing) residential leadership commitment to cessation improvement. These dual features, along with adaptable elements that can be modified to a variety of local/national housing settings, defines how the investigator's project will overcome the implementation gaps defining failed smoking cessation efforts in lower-income settings. The objective of this project is to test the feasibility of the intervention package among local housing contextual factors that could impact both the acceptability and adoptability of the investigator's project. Using a collection of formative and implementation evaluation measures, the investigator's academic-community partnership project is well positioned to create an adaptable and customizable intervention that can be scaled in similar housing populations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lower socioeconomic populations continue to remain at high risk for tobacco use and suffer disproportionately from tobacco-related disease. Evidence is lacking of ways to optimally deliver behavioral and pharmaceutical-based cigarette smoking cessation interventions in real-world environments among disadvantaged cohorts where geographic, socioeconomic and technological disparities often undermine the effectiveness of evidence-based smoking cessation efforts. The investigator's study focuses on residents of public housing in Baltimore City, a population who face multiple socioeconomic stressors and of whom up to 1/3 are assumed conventional cigarette users.

The investigator's project uses a partnership between the Housing Authority of Baltimore City (HABC) and Johns Hopkins School of Medicine to enact a remote (off-site) cessation program in two public housing complexes under the management of HABC. The investigator's program will institute evidence-based practices in an accessible manner for the residents at both sites. The investigator's program's key features include the remote recruitment, prescription, delivery and management of evidence-based nicotine pharmacotherapies, and provision of cessation counseling.

To assess the feasibility of study design, the investigator's project specifically focuses on the following eight elements: a) recruitment of smokers expressing a motivation to reduce or quit smoking, b) Consent process, c) nicotine and non-nicotine pharmacotherapy selection, screening, prescription, delivery, storage management (participation education, side-effecting monitoring), and return of unused drug supplies, d) Administration and perceived utility of motivational interviewing regarding smoking reduction and cessation, e) Delivery of study reimbursement, f) Utility of weekly text reminders of study participation and final endpoint, g) acceptability of outcome measures, h) acceptability and evaluation of joint project oversight with community stakeholders.

The project will enroll eighty participants to determine feasibility endpoints. All participants will receive the intervention, as preferred by community partners. Participants will serve as the participants own control, which in turn means that the investigators will compare the intervention's effect at an individual level. All participants will be offered over a 4-week period both a long-acting nicotine controller medication (varenicline or nicotine patch) and short-acting medication to address acute urges to smoke (nicotine gum/lozenge). Each week participants will be monitored and receive cessation-directed counseling. If medication questions or concerns arise, patients will have access to 24-hour phone support. The results of the project will be reviewed with participants, community partners and academic team.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Panagis S. Galiatsatos, MD, MHS
  • Phone Number: 4105502184
  • Email: pgaliat1@jh.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Creative Alternative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥18 years of age to 99 years old
  • Self-reported smoker with either daily or weekly cigarette use, as well as expressed desire to reduce or quit smoking
  • Proof of residence at Douglass or Brooklyn Homes through verbal acknowledgement by the Service Coordinators at each of the public housing sites.
  • Working cell phone with ability to text for the duration of the study
  • Active health insurance (for pharmacotherapy billing)

Exclusion Criteria:

  • Pregnant - women will verbally acknowledge that they are not pregnant
  • Breastfeeding - women who are verbally acknowledge they are breastfeeding will be excluded from the study.
  • Ongoing participation in a tobacco cessation program or related tobacco intervention study
  • Unable to verbally state that they are willing to reduce or quit smoking upon recruitment and screening
  • Adults lacking capacity to consent
  • Non-English speakers
  • Self-reported usage of only non-combustible tobacco products, such as smokeless tobacco or Electronic Nicotine Delivery Devices (ENDS).
  • Anticipated relocation outside of Douglass or Brooklyn Homes prior to the final study visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cessation intervention
Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Other: Cessation Intervention
  1. Pharmacotherapy selection, prescription and monitoring of up to two types of cessation pharmacotherapies: Nicotine replacement therapy (gum, lozenge and transdermal patch) and non-nicotine replacement therapy (varenicline).
  2. Remote video-conferencing and mobile phone-based, personalized motivational messaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Nicotine Dependence (Short Form 8a) Score
Time Frame: Baseline, 4 weeks

This outcome measures assesses cravings or withdrawal that occurs upon brief cessation of smoking, smoking temptations, compulsive use, and tolerance.

The scores range from 8 - 40. The lower end of the range indicates no nicotine dependence and the upper end of the range correlates with a high degree of dependence.
Baseline, 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PROMIS Coping Expectancies (Short Form 4a) Score
Time Frame: Baseline, 4 weeks

This outcome measure assesses smokers' tendency to use smoking as a means of coping with negative affect and stress.

The scores range from 4 - 20. A score of 4 indicates cigarettes are not being used to cope with life experience and mental health; a maximum of 20 indicates cigarettes are being used always or very much to address both negative life experiences and mental health.
Baseline, 4 weeks
Change in PROMIS Emotional and Sensory Expectancies (Short Form 6a) Score
Time Frame: Baseline, 4 weeks

This outcome measure assesses perceptions of improved cognitive abilities, positive affective states, and pleasurable sensorimotor sensations due to smoking.

The scores range from 6 - 30. A score of 6 indicates cigarettes are not being used to enhance emotional and sensory experiences; a maximum of 30 indicates cigarettes are strongly (or very much) used to improve both emotional and sensory experiences.
Baseline, 4 weeks
Change in PROMIS Health Expectancies (Short Form 6a) Score
Time Frame: Baseline, 4 weeks

This outcome measure assesses perceptions of improved cognitive abilities, positive affective states, and pleasurable sensorimotor sensations due to smoking.

The scores range from 6 - 30. A score of 6 indicates smoking cigarettes are not perceived at all as being associated with negative health experiences, including changes in cognition, affect and sensorimotor sensations; a score of 30 translates to a perception that cognition, affect and sensorimotor sensations are very much associated with smoking.
Baseline, 4 weeks
Change in PROMIS Psychosocial Expectancies (Short Form 6a) Score
Time Frame: Baseline, 4 weeks

This outcome measure assesses smokers' beliefs about aspects of social disapproval and disappointment in oneself that are experienced as a result of smoking.

The scores range from 6 - 30. A score of 6 indicates smoking cigarettes are not perceived at all as being associated with social disapproval and disappointment in oneself; a score of 30 translates to a perception that smoking is very much associated with social disapproval and disappointment in oneself
Baseline, 4 weeks
Change in PROMIS Social Motivations (Short Form 4a) Score
Time Frame: Baseline, 4 weeks

This outcome measure assesses smokers' assesses self-reported social factors that influence smoking behavior.

The range of scores is from 4 - 20. A score of 4 indicates there is not any perceived association between smoking and social factors; a score of 20 indicates a very strong perception that smoking is associated with social factors.
Baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)
Community Partnership and Collaboration Core Pilot Grant

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Panagis Galiatsatos, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00224186
  • UL1TR003098 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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