This study is not yet accepting patients

Intervention for Tobacco Use for People Experiencing Homelessness

a study on Smoking Cessation Tobacco Homelessness Nicotine

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Maya Vijayaraghavan, MD (ucsf)
Headshot of Maya Vijayaraghavan
Maya Vijayaraghavan

Description

Summary

This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Keywords

Tobacco Cessation, Tobacco Abstinence, Tobacco Use, Tobacco Use Cessation, Tobacco Dependence, Tobacco Use Disorder, Nicotine Replacement Therapy, Nicotine Replacement Therapy (NRT), Wellness Coaching

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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).

Location

  • University of California, San Francisco
    San Francisco 5391959 California 5332921 94143 United States

Lead Scientist at University of California Health

  • Maya Vijayaraghavan, MD (ucsf)
    Dr. Vijayaraghavan is a practicing general internist and a researcher in tobacco control with a focus on populations experiencing homelessness. She is the Director of the UCSF Smoking Cessation Leadership Center, a Center focused on eliminating disparities in tobacco use prevalence among behavioral health populations.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07148232
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated