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

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.

Inclusion criteria

• Age 18 years or older
• Able to understand study procedures and to comply with them for the entire length of the study.
• Ability of individual to understand a written informed consent document, and the willingness to sign it.
• Staying at the recruitment site and meeting criteria for homelessness as defined by the Homeless Emergency and Rapid Transition to Housing Act.
• Current smoking (smoking at least 5 cigarettes per day (cpd), verified via expired carbon monoxide (CO) >= 8 ppm using Micro+pro Smokerlyzer).
• Having an intention to quit smoking within the next six months.
• English speaking.

Exclusion criteria

• Contraindication to any study-related procedure or assessment.
• Reasons that preclude the use of nicotine replacement therapy (NRT) (e.g., pregnancy or myocardial infarction in the past two weeks).