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

NCT ID: NCT07148232

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-14
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Tobacco Cessation; Tobacco Abstinence; Tobacco Use; Tobacco Use Cessation; Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (extended intervention for tobacco use)

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.

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy (NRT)

Intervention Type: DRUG

NRT will be administered as patch (transdermal), gum, or lozenge

Wellness Coaching

Intervention Type: BEHAVIORAL

Delivered via phone call

Pharm-only

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.

Group Type: OTHER

Nicotine Replacement Therapy (NRT)

Intervention Type: DRUG

NRT will be administered as patch (transdermal), gum, or lozenge

Interventions

Nicotine Replacement Therapy (NRT)

NRT will be administered as patch (transdermal), gum, or lozenge

Intervention Type: DRUG

Wellness Coaching

Delivered via phone call

Intervention Type: BEHAVIORAL

Other Intervention Names

NRT

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tobacco Related Disease Research Program

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maya Vijayaraghavan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Alway

Role: CONTACT

jessica.alway@ucsf.edu

877-827-3222

Facility Contacts

Jessica Alway

Role: primary

jessica.alway@ucsf.edu

877-827-3222

Maya Vijayaraghavan, MD

Role: backup

maya.vijayaraghavan@ucsf.edu

628-206-6959

Other Identifiers

NCI-2025-08620

Identifier Type: REGISTRY

Identifier Source: secondary_id

25632

Identifier Type: -

Identifier Source: org_study_id