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

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Tobacco Dependence; Tobacco Abstinence; Tobacco Use Cessation; Tobacco Cessation; Tobacco Use

Treatments: Drug: Nicotine Replacement Therapy (NRT); Behavioral: Wellness Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT07148232

25632

NCI-2025-08620 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Treatment (extended intervention for tobacco use)

Experimental group

Description:

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.

Treatment:

Behavioral: Wellness Coaching

Drug: Nicotine Replacement Therapy (NRT)

Pharm-only

Other group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy (NRT)