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Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness

Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness

Recruiting
18 years and older
All
Phase 4

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Overview

This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.

Description

PRIMARY OBJECTIVES:

I. Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up.

II. Use expired carbon monoxide (CO) to confirm self-reports of abstinence using a cut-off of CO ≤5 parts per million (ppm).

SECONDARY OBJECTIVES:

I. Biochemically-verified 7-day point prevalence tobacco abstinence at 3-months follow-up.

II. Measured at 6-months follow-up, a total number of expired carbon monoxide (CO-negative samples).

III. Measured at 6-months follow-up, longest duration of abstinence (i.e., total number of uninterrupted days abstinent), proportion with 50% reduction in expired CO for those who do not quit smoking.

IV. Use expired CO to confirm self-reports of abstinence using a cut-off of CO ≤5 ppm.

OUTLINE

Participants will be randomized to one of two groups:

  • Intervention group receives 6 months of pharmacist consultation, monthly delivery of nicotine replacement therapy, and telephone wellness coaching.
  • Control group receives pharmacist consultation and monthly delivery of nicotine replacement therapy for 3 months.

Participants will be followed up at 1, 3 and 6 months.

Eligibility

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).

Study details
    Tobacco Cessation
    Tobacco Abstinence
    Tobacco Use
    Tobacco Use Cessation
    Tobacco Dependence

NCT07148232

University of California, San Francisco

31 January 2026

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