Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness

Phase 4RecruitingNCT07148232

University of California, San Francisco150 enrolled

Overview

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: * 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Tobacco Cessation Tobacco Abstinence Tobacco Use Tobacco Use Cessation Tobacco Dependence

Interventions

Nicotine Replacement Therapy (NRT)DRUG

NRT will be administered as patch (transdermal), gum, or lozenge

Wellness CoachingBEHAVIORAL

Delivered via phone call

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 years or older 2. Able to understand study procedures and to comply with them for the entire length of the study. 3. Ability of individual to understand a written informed consent document, and the willingness to sign it. 4. Staying at the recruitment site and meeting criteria for homelessness as defined by the Homeless Emergency and Rapid Transition to Housing Act. 5. Current smoking (smoking at least 5 cigarettes per day (cpd), verified via expired carbon monoxide (CO) \>= 8 ppm using Micro+pro Smokerlyzer). 6. Having an intention to quit smoking within the next six months. 7. English speaking. Exclusion Criteria: 1. Contraindication to any study-related procedure or assessment. 2. Reasons that preclude the use of nicotine replacement therapy (NRT) (e.g., pregnancy or myocardial infarction in the past two weeks).

Locations (1)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 3 months

Central Contacts

Jessica Alway

CONTACT

877-827-3222 jessica.alway@ucsf.edu

Data from ClinicalTrials.gov

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