Trials / Recruiting
RecruitingNCT07148232
Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nicotine Replacement Therapy (NRT) | NRT will be administered as patch (transdermal), gum, or lozenge |
| BEHAVIORAL | Wellness Coaching | Delivered via phone call |
Timeline
- Start date
- 2025-11-14
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
- First posted
- 2025-08-29
- Last updated
- 2025-11-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07148232. Inclusion in this directory is not an endorsement.