Extended tobacco support for people experiencing homelessness
Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
This program tests whether extending tobacco treatment to 6 months with pharmacist counseling, monthly nicotine replacement deliveries, and phone wellness coaching helps adults experiencing homelessness quit smoking compared with a 3-month package.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07148232 on ClinicalTrials.gov |
What this trial studies
Adults experiencing homelessness who smoke are randomized to receive either 6 months of pharmacist consultation plus monthly nicotine replacement therapy (NRT) deliveries and telephone wellness coaching, or a control arm that receives pharmacist consultation and monthly NRT for 3 months. Abstinence is measured at 1, 3, and 6 months with self-report confirmed by expired carbon monoxide (CO) using a ≤5 ppm cut-off. Primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months; secondary outcomes include 3-month abstinence, total CO-negative samples, and longest continuous abstinence. The intervention is delivered in community settings in California and targets people meeting federal homelessness criteria who smoke at least 5 cigarettes per day and plan to quit within six months.
Who should consider this trial
Good fit: Adults (18+) experiencing homelessness in the study locations who smoke ≥5 cigarettes per day, intend to quit in the next six months, can consent and communicate in English are ideal candidates.
Not a fit: People with contraindications to NRT (for example pregnancy or recent myocardial infarction), those not intending to quit, or those unable to comply with study procedures or language requirements are unlikely to benefit.
Why it matters
Potential benefit: If successful, the extended program could raise quit rates and reduce tobacco-related harm among people experiencing homelessness.
How similar studies have performed: Combined pharmacotherapy and counseling reliably improves quit rates in general populations and prior pilot work among people experiencing homelessness has shown limited but promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. Able to understand study procedures and to comply with them for the entire length of the study. 3. Ability of individual to understand a written informed consent document, and the willingness to sign it. 4. Staying at the recruitment site and meeting criteria for homelessness as defined by the Homeless Emergency and Rapid Transition to Housing Act. 5. Current smoking (smoking at least 5 cigarettes per day (cpd), verified via expired carbon monoxide (CO) \>= 8 ppm using Micro+pro Smokerlyzer). 6. Having an intention to quit smoking within the next six months. 7. English speaking. Exclusion Criteria: 1. Contraindication to any study-related procedure or assessment. 2. Reasons that preclude the use of nicotine replacement therapy (NRT) (e.g., pregnancy or myocardial infarction in the past two weeks).
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Maya Vijayaraghavan, MD — University of California, San Francisco
- Study coordinator: Jessica Alway
- Email: jessica.alway@ucsf.edu
- Phone: 877-827-3222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.