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

NCT07148232 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 25632NCI-2025-08620
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 7-day point prevalence tobacco abstinence at month 3

  3 months

Study Arms (2)

Treatment (extended intervention for tobacco use)

EXPERIMENTAL

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.

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

Pharm-only

OTHER

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)

Interventions

Nicotine Replacement Therapy (NRT) DRUG

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

Also known as: NRT

Pharm-only; Treatment (extended intervention for tobacco use)

Wellness Coaching BEHAVIORAL

Delivered via phone call

Treatment (extended intervention for tobacco use)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use; Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Maya Vijayaraghavan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Alway

CONTACT

877-827-3222; jessica.alway@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)