Tobacco Cessation, Tobacco Abstinence, Tobacco Use, Tobacco Use Cessation, Tobacco Dependence
Conditions
Brief 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.
Interventions
DRUGNicotine Replacement Therapy (NRT)
NRT will be administered as patch (transdermal), gum, or lozenge
BEHAVIORALWellness Coaching
Delivered via phone call
Sponsors
Tobacco Related Disease Research Program
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who attended coaching sessions | up to 6 months | The percentage of participants who attended at least 75% or 7 of the 14 coaching sessions will be reported. |
| Percentage of participants who used nicotine replacement therapy (NRT) | up to 6 months | 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. |
| 7-day point prevalence tobacco abstinence at month 6 | 6 months | Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence tobacco abstinence at month 3 | 3 months | Biochemically verified 7-day point prevalence tobacco abstinence at 3-months follow-up will be reported. |
Countries
United States
Contacts
Primary ContactJessica Alway
Outcome results
None listed