This phase II trial compares the extended intervention for tobacco (EXIT) to the pharmacist only intervention to improve tobacco cessation for people experiencing homelessness. Tobacco use prevalence is high and is among the leading cause of death among people experiencing homelessness. The EXIT intervention was developed to provide more support than the standard duration of 12 weeks of nicotine replacement therapy and counseling for cessation. It includes health coach delivered wellness focused coaching to help address tobacco use that may be occurring along with metal health, substance-use and other life stressors. The EXIT intervention may be more effective than the pharmacist only intervention to improve tobacco cessation in people experiencing homelessness.
Additional locations may be listed on ClinicalTrials.gov for NCT07148232.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Maya Vijayaraghavan
Phone: 617-817-8738
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and acceptability (F&A) of the EXIT protocol and the preliminary efficacy of EXIT compared to the pharm-only condition on tobacco abstinence at 6-months follow-up.
EXPLORATORY OBJECTIVES:
I. Total number of expired carbon monoxide (CO)-negative samples.
II. Longest duration of abstinence.
III. Proportion with ≥ 50% reduction in expired CO.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete a session with a pharmacist, using the Ask, Advice, Assess, Assist and Arrange model to plan for tobacco cessation and nicotine replacement therapy. Patients receive delivery of nicotine replacement therapy once per month for 6 months. Patients also receive health coach delivered wellness focused coaching, to help patients navigate nicotine replacement therapy use, manage side effects and assist in medication changes if needed, via the telephone weekly for months 1 and 2, biweekly for months 3 and 4 and monthly for months 5 and 6.
ARM II: Patients complete a session with a pharmacist, using the Ask, Advice, Assess, Assist and Arrange model to plan for tobacco cessation and nicotine replacement therapy. Patients receive delivery of nicotine replacement therapy once per month for 3 months.
After completion of study intervention, patients are followed up at 6 months.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorMaya Vijayaraghavan
