Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Extended tobacco support for people experiencing homelessness

Official title: Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness

Run by University of California, San Francisco · NCT07148232 · Data updated 2026-11-12

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedNovember 14, 2025
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedNovember 21, 2025
Trial IDNCT07148232 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.