Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Smartphone-delivered automated treatment; Behavioral: Counceling

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated Treatment; 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	Drug: Nicotine patch; Participants will be provided with a 10-week supply of nicotine patches; Drug: Nicotine lozenge; Participants will be provided with a 10-week supply of nicotine lozenges; Behavioral: Smartphone-delivered automated treatment; An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant
Active Comparator: Standard Treatment; 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; Participants will be provided with a 10-week supply of nicotine patches; Drug: Nicotine lozenge; Participants will be provided with a 10-week supply of nicotine lozenges; Behavioral: Counceling; Phone counseling with the Florida Quitline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Damon J Vidrine, Dr.PH, Moffitt Cancer Center; Principal Investigator: Jennifer I Vidrine, Ph.D., Moffitt Cancer Center

Publications and helpful links

General Publications

• Vidrine JI, Shih YT, Businelle MS, Sutton SK, Hoover DS, Cottrell-Daniels C, Fennell BS, Bowles KE, Vidrine DJ. Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial. BMC Public Health. 2022 Mar 22;22(1):563. doi: 10.1186/s12889-022-12840-7.

Helpful Links

• Moffitt Cancer Center Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): August 19, 2025

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Therapeutics; Tobacco Use Cessation Devices
• Other Study ID Numbers: MCC-20154; 5R01CA231952-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No