Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT07148232
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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:
* 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.
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:
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-08620 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |