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

NCT07148232 — Phase 4, Recruiting, 150 participants, University of California, San Francisco

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Registry	NCT07148232
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	University of California, San Francisco (Other); collaborators: Tobacco Related Disease Research Program
Conditions	Tobacco Cessation, Tobacco Abstinence, Tobacco Use, Tobacco Use Cessation, Tobacco Dependence
Interventions	Nicotine Replacement Therapy (NRT), Wellness Coaching (Drug, behavioral)
Dates	start 2025-11-14, primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2025-08-29, last updated 2025-11-21
Locations	1 site in United States

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment (extended intervention for tobacco use)	Experimental	Drug: Nicotine Replacement Therapy (NRT); Behavioral: Wellness Coaching	Participants receive pharmacist provided one-time tobacco treatment using the five As: Ask, Advise, Assess, Assist and Arrange (5As) model and receives an initial monthly delivery of nicotine replacement therapy (NRT) for 3 months. Participants then receive the extended intervention for tobacco use (EXIT) that consists of: 1) health coach-delivered, weekly-to-monthly wellness-focused telephone coaching for 6 months addressing tobacco use within the context of co-occurring psychiatric and substance-use comorbidities and other life stressors, and 2) an additional session of pharmacist-delivered 5As with monthly delivery of NRT for an additional 6 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.
Pharm-only	Other	Drug: Nicotine Replacement Therapy (NRT)	Participants receive pharmacist provided one-time tobacco treatment using the 5As and receive monthly delivery of NRT for 3 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.

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

+Outcome measures

Primary outcomes

Percentage of participants who attended coaching sessions [up to 6 months]: The percentage of participants who attended at least 75% or 7 of the 14 coaching sessions will be reported.
Percentage of participants who used nicotine replacement therapy (NRT) [up to 6 months]: The percentage of participants who used at least 75% will adhere to using NRT for at least half of the treatment duration will be reported.
7-day point prevalence tobacco abstinence at month 6 [6 months]: Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up will be reported.

Secondary outcomes

7-day point prevalence tobacco abstinence at month 3 [3 months]: Biochemically verified 7-day point prevalence tobacco abstinence at 3-months follow-up will be reported.

+Eligibility

Sex: All, ages: 18 Years to any

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).

+Locations (1)

Facility	City	Country	Status
University of California, San Francisco	San Francisco, California	United States	Recruiting

+Investigators

Maya Vijayaraghavan, MD, Principal investigator, University of California, San Francisco

My Notes

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