Smoking CessationNCT04889638
Tobacco Cessation in Public Housing
A study testing Cessation Intervention in people with Smoking Cessation and Smoking Reduction, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking Reduction, Smoking, Tobacco
- What is being tested?
- Cessation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Smoking Reduction, Smoking, Tobacco
- Being tested
- Cessation Intervention
- Medical subject headings
- Smoking Cessation, Smoking Reduction, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation InterventionOther
- 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).
- Remote video-conferencing and mobile phone-based, personalized motivational messaging
| Study group | Role | What they receive |
|---|---|---|
| Cessation intervention | Experimental | 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. Receives: Other: Cessation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Nicotine Dependence (Short Form 8a) Score
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.
Measured: Baseline, 4 weeks
Secondary outcomes (5)
Change in PROMIS Coping Expectancies (Short Form 4a) Score
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.
Measured: Baseline, 4 weeks
Change in PROMIS Emotional and Sensory Expectancies (Short Form 6a) Score
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.
Measured: Baseline, 4 weeks
Change in PROMIS Health Expectancies (Short Form 6a) Score
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.
Measured: Baseline, 4 weeks
Change in PROMIS Psychosocial Expectancies (Short Form 6a) Score
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
Measured: Baseline, 4 weeks
Change in PROMIS Social Motivations (Short Form 4a) Score
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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start3 Apr 2024
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Community Partnership and Collaboration Core Pilot Grant
- Responsible party
- Sponsor
- Investigators
- Panagis Galiatsatos, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889638
- Sponsor's protocol ID
- IRB00224186
- Other IDs
- UL1TR003098
- Status last verified
- Jan 2026
- First submitted
- 12 May 2021
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Tobacco Cessation for Residents of Baltimore City Public Housing
- ClinicalTrials.gov ID
- NCT04889638
- Acronym / sponsor ID
- IRB00224186
- Conditions
- Smoking Cessation, Smoking Reduction, Smoking, Tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), Community Partnership and Collaboration Core Pilot Grant
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study design
| Arm | Type | Receives |
|---|---|---|
| Cessation intervention | Experimental | Other: Cessation InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cessation Intervention1. 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 | Other | Cessation intervention |
Primary outcome
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.
5 secondary outcomes
Change in PROMIS Coping Expectancies (Short Form 4a) Score
Time frame: Baseline, 4 weeks
Change in PROMIS Emotional and Sensory Expectancies (Short Form 6a) Score
Time frame: Baseline, 4 weeks
Change in PROMIS Health Expectancies (Short Form 6a) Score
Time frame: Baseline, 4 weeks
Change in PROMIS Psychosocial Expectancies (Short Form 6a) Score
Time frame: Baseline, 4 weeks
Change in PROMIS Social Motivations (Short Form 4a) Score
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagis Galiatsatos principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation Intervention in people with Smoking Cessation and Smoking Reduction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Nicotine Dependence (Short Form 8a) Score (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.