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

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

Study Overview

• Status: Recruiting
• Conditions: Tobacco Cessation; Tobacco Use; Tobacco Use Cessation; Tobacco Dependence; Tobacco Abstinence
• Intervention / Treatment: Behavioral: Wellness Coaching; Drug: Nicotine Replacement Therapy (NRT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jessica Alway; Phone Number: 877-827-3222; Email: jessica.alway@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Jessica Alway; Phone Number: 877-827-3222; Email: jessica.alway@ucsf.edu
      • Contact: Maya Vijayaraghavan, MD; Phone Number: 628-206-6959; Email: maya.vijayaraghavan@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Wellness Coaching; Delivered via phone call; Drug: Nicotine Replacement Therapy (NRT); NRT will be administered as patch (transdermal), gum, or lozenge; Other Names: NRT
Other: 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.	Drug: Nicotine Replacement Therapy (NRT); NRT will be administered as patch (transdermal), gum, or lozenge; Other Names: NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who attended coaching sessions	The percentage of participants who attended at least 75% or 7 of the 14 coaching sessions will be reported.	up to 6 months
Percentage of participants who used nicotine replacement therapy (NRT)	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.	up to 6 months
7-day point prevalence tobacco abstinence at month 6	Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up will be reported.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point prevalence tobacco abstinence at month 3	Biochemically verified 7-day point prevalence tobacco abstinence at 3-months follow-up will be reported.	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Tobacco Related Disease Research Program
• Investigators: Principal Investigator: Maya Vijayaraghavan, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: August 22, 2025
• First Submitted That Met QC Criteria: August 22, 2025
• First Posted (Estimated): August 29, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Tobacco Use Disorder; Tobacco Use; Tobacco Use Cessation; Therapeutics; Drug Therapy; Nicotine Replacement Therapy
• Other Study ID Numbers: 25632; NCI-2025-08620 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No