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Recruiting NCT07148232

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

Phase IV Interventional Tobacco Cessation Tobacco Abstinence Tobacco Use Tobacco Use Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicotine Replacement Therapy (NRT), Wellness Coaching.
Who it may be relevant to
Registry conditions: Tobacco Cessation, Tobacco Abstinence, Tobacco Use, Tobacco Use Cessation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Drug Nicotine Replacement Therapy (NRT)
    NRT will be administered as patch (transdermal), gum, or lozenge
  • Behavioral Wellness Coaching
    Delivered via phone call

Primary outcome measures

  • Percentage of participants who attended coaching sessions [Time frame: up to 6 months]
  • Percentage of participants who used nicotine replacement therapy (NRT) [Time frame: up to 6 months]
  • 7-day point prevalence tobacco abstinence at month 6 [Time frame: 6 months]
Secondary outcome measures (1)
  • 7-day point prevalence tobacco abstinence at month 3 [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older
  • Able to understand study procedures and to comply with them for the entire length of the study.
  • Ability of individual to understand a written informed consent document, and the willingness to sign it.
  • Staying at the recruitment site and meeting criteria for homelessness as defined by the Homeless Emergency and Rapid Transition to Housing Act.
  • Current smoking (smoking at least 5 cigarettes per day (cpd), verified via expired carbon monoxide (CO) >= 8 ppm using Micro+pro Smokerlyzer).
  • Having an intention to quit smoking within the next six months.
  • English speaking.

Exclusion criteria

  • Contraindication to any study-related procedure or assessment.
  • Reasons that preclude the use of nicotine replacement therapy (NRT) (e.g., pregnancy or myocardial infarction in the past two weeks).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07148232 · 25632 · NCI-2025-08620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗