Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

Study Overview
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Brief Summary
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This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.

Official Title
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Partnering With a State Food Bank to Provide Tobacco Treatment to Underserved Smokers (Project NOURISH)

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smartphone-delivered automated treatment
* Drug: Nicotine patch
* Behavioral: Counceling
* Drug: Nicotine lozenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >100 lifetime cigarettes English or Spanish speaking Currently smoke > 5 cigarettes/day Process a smartphone compatible with the project app Have a valid email address Exclusion Criteria: Currently pregnant or breastfeeding Current use of smoking cessation medications Enrolled in a smoking cessation study Household member enrolled in the study Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Treatment<br>Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress. | Drug: Nicotine patch<br>* Participants will be provided with a 10-week supply of nicotine patches<br>Behavioral: Counceling<br>* Phone counseling with the Florida Quitline<br>Drug: Nicotine lozenge<br>* Participants will be provided with a 10-week supply of nicotine lozenges<br>|
| Experimental: Automated Treatment<br>Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content | Behavioral: Smartphone-delivered automated treatment<br>* An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant<br>Drug: Nicotine patch<br>* Participants will be provided with a 10-week supply of nicotine patches<br>Drug: Nicotine lozenge<br>* Participants will be provided with a 10-week supply of nicotine lozenges<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported 7 Day Abstinence Smoking Status | Participants will self report 7-day abstinence smoking status | 12 Month Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status by Saliva Cotinine Kit | Investigators will verify smoking status by collecting cotinine sample from a saliva cotinine kit. | 12 Month Follow-Up | 
| Self Reported 24 Hours Smoking Abstinence | Number of participants who report they quit smoking for 24 hours | 12 Month Follow-Up | 
| 30 Day Smoking Abstinence | Number of participants who report they quit smoking for 30 days | 12 Month Follow-Up | 
| Continuous Smoking Abstinence | Number of participants who report they quit smoking | 12 Month Follow-Up |