Tobacco Cessation in Public Housing

NCT04889638 | Completed Results

• 2 other identifiers: IRB00224186UL1TR003098
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking Cessation; Smoking Reduction; Smoking, Tobacco

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks

Secondary Outcomes (5)

• Change in PROMIS Coping Expectancies (Short Form 4a) Score

  Baseline, 4 weeks

• Change in PROMIS Emotional and Sensory Expectancies (Short Form 6a) Score

  Baseline, 4 weeks

• Change in PROMIS Health Expectancies (Short Form 6a) Score

  Baseline, 4 weeks

• Change in PROMIS Psychosocial Expectancies (Short Form 6a) Score

  Baseline, 4 weeks

• Change in PROMIS Social Motivations (Short Form 4a) Score

  Baseline, 4 weeks

Study Arms (1)

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.

Other: Cessation Intervention

Interventions

Cessation Intervention OTHER

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

Cessation intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Community Partnership and Collaboration Core Pilot Grant: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Creative Alternative

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking Reduction; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Results Point of Contact

• Title: Panagis Galiatsatos, MD, MHS
• Organization: Johns Hopkins University School of Medicine

pgaliat1@jh.edu

4104934866

Study Officials

• Panagis Galiatsatos

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post study design

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: April 3, 2024
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Locations

US (1)