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Completed
NCT07897058
Project E-Shift: A Harm Reduction Intervention for Chronically Unhoused Smokers.
Conditions: Cigarette Smoking Behavior, E-Cigarette Use
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 44
Sponsor: Thomas Jefferson University
Location: Pathways to Housing Philadelphia Pennsylvania
Summary
This pilot randomized trial tested whether switching to e-cigarettes, compared with standard nicotine replacement therapy (NRT; patch and gum), helped adults with a history of chronic homelessness stop smoking combustible cigarettes. All participants received brief cessation counseling and incentives for carbon monoxide (CO)-verified abstinence from cigarettes during the first weeks after a scheduled switch date. Participants were followed for 12 weeks after switching, with a final follow-up at 24 weeks. The study also assessed feasibility (recruitment, retention, and visit attendance) and used interviews with participants and service-agency staff to understand acceptability and how a tobacco harm reduction program could fit into existing housing and clinic services.
Eligibility Criteria
Inclusion Criteria:
* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study.
* Male or female aged 21 and above.
* expired CO \>6 ppm at screening
* People of reproductive potential must not be pregnant nor trying to become pregnant.
* Adequate literacy to complete self-administered study questionnaires, defined as a score ≥4 out of 7 on the Rapid Estimate of Adult Literacy in Medicine - Short Form (REALM-SF), corresponding to a 7th-grade reading level or higher
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
* Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded.
* Medical condition that precludes participation
* Current use of THC-containing vaping products
* Pregnancy or lactation
* Known allergic reactions to components of the study product(s)
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Source: ClinicalTrials.gov (NCT07897058). StuddyBuddy aggregates publicly available trial information.