Recruiting

Tobacco Treatment

Sponsor:

UCLA

Code:

NCT07148232

Conditions

Tobacco Cessation

Tobacco Abstinence

Tobacco Use

Tobacco Use Cessation

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nicotine Replacement Therapy (NRT)

Wellness Coaching

Study Details

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

Study ID

NCT07148232

Start date

Nov 14, 2025

Status verified date

Nov, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Nicotine Replacement Therapy (NRT)

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

Wellness Coaching

Delivered via phone call

Primary outcome measure

  • Percentage of participants who attended coaching sessions [ Time Frame: up to 6 months ]
  • Percentage of participants who used nicotine replacement therapy (NRT) [ Time Frame: up to 6 months ]
  • 7-day point prevalence tobacco abstinence at month 6 [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jessica Alway

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jessica Alway

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

Maya Vijayaraghavan, MD

628-206-6959maya.vijayaraghavan@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-11-21.