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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08620 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
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This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.
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:
Participants will be followed up at 1, 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy (NRT) | Drug | NRT will be administered as patch (transdermal), gum, or lozenge |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Alway | Contact | 877-827-3222 | jessica.alway@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maya Vijayaraghavan, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Wellness Coaching | Behavioral | Delivered via phone call |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D064424 | Tobacco Use |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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