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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07148232
Phase
PHASE4
Status
Recruiting
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Conditions

  • Tobacco Abstinence
  • Tobacco Cessation
  • Tobacco Dependence
  • Tobacco Use
  • Tobacco Use Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicotine Replacement Therapy (NRT) — DRUG
    NRT will be administered as patch (transdermal), gum, or lozenge
  • Wellness Coaching — BEHAVIORAL
    Delivered via phone call

Study Details

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

Key Dates

Start date
Nov 14, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage of participants who attended coaching sessions [ Time Frame: up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Jessica Alway
[email protected]
877-827-3222
Maya Vijayaraghavan, MD
[email protected]
628-206-6959

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