Tobacco CessationPhase 4NCT07148232
Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
A Phase 4 study testing Nicotine Replacement Therapy (NRT) and Wellness Coaching in people with Tobacco Cessation and Tobacco Abstinence, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Cessation, Tobacco Abstinence, Tobacco Use
- What is being tested?
- Nicotine Replacement Therapy (NRT) and Wellness Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Jessica Alway, 877-827-3222, jessica.alway@ucsf.edu
Maya Vijayaraghavan, MD, 628-206-6959, maya.vijayaraghavan@ucsf.edu
About this study
This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- Nicotine Replacement Therapy (NRT), Wellness Coaching
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement Therapy (NRT)Drug
Also called NRT
NRT will be administered as patch (transdermal), gum, or lozenge
Wellness CoachingBehavioural
Delivered via phone call
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Nicotine Replacement Therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start14 Nov 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Maya Vijayaraghavan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148232
- Sponsor's protocol ID
- 25632
- Other IDs
- NCI-2025-08620
- Status last verified
- Nov 2025
- First submitted
- 22 Aug 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT07148232
- Acronym / sponsor ID
- 25632
- Conditions
- Tobacco Cessation, Tobacco Abstinence, Tobacco Use, Tobacco Use Cessation, Tobacco Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (extended intervention for tobacco use) | Experimental | Drug: Nicotine Replacement Therapy (NRT), Behavioral: Wellness CoachingParticipants 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. |
| Pharm-only | Other | Drug: Nicotine Replacement Therapy (NRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy (NRT)Also: NRTNRT will be administered as patch (transdermal), gum, or lozenge | Drug | Pharm-only, Treatment (extended intervention for tobacco use) |
| Wellness CoachingDelivered via phone call | Behavioural | Treatment (extended intervention for tobacco use) |
Primary outcome
Percentage of participants who attended coaching sessions
Time frame: up to 6 months
The percentage of participants who attended at least 75% or 7 of the 14 coaching sessions will be reported.
Percentage of participants who used nicotine replacement therapy (NRT)
Time frame: up to 6 months
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.
7-day point prevalence tobacco abstinence at month 6
Time frame: 6 months
Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up will be reported.
1 secondary outcome
7-day point prevalence tobacco abstinence at month 3
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya Vijayaraghavan, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Therapy (NRT) and Wellness Coaching in people with Tobacco Cessation and Tobacco Abstinence, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Alway (877-827-3222, jessica.alway@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who attended coaching sessions (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.