Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

NCT05004662 | Completed Results

• 2 other identifiers: MCC-20154R01CA231952
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Self-Reported 7-Day Point-Prevalence Smoking Abstinence

  Participants who report no smoking, not even a puff, within the past 7 days

  12 Month Follow-Up

Secondary Outcomes (3)

• Biochemical Verification Via Salivary Cotinine

  12 Month Follow-Up

• Self-Reported 24-Hour Point-Prevalence Smoking Abstinence

  12 Month Follow-Up

• Self-Reported 30-Day Point-Prevalence Smoking Abstinence

  12 Month Follow-Up

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

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; Behavioral: Counseling; Drug: Nicotine lozenge

Automated Treatment

EXPERIMENTAL

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 negative affect/stress; 2) 26 weeks of on-demand access to treatment content that is tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.

Behavioral: Smartphone-delivered automated treatment; Drug: Nicotine patch; Drug: Nicotine lozenge

Interventions

Smartphone-delivered automated treatment BEHAVIORAL

An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants

Automated Treatment

Nicotine patch DRUG

Participants will be provided with a 10-week supply of nicotine patches

Automated Treatment; Standard Treatment

Nicotine lozenge DRUG

Participants will be provided with a 10-week supply of nicotine lozenges

Automated Treatment; Standard Treatment

Counseling BEHAVIORAL

Smoking cessation treatment delivery by State Quitline's

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• Receipt of food assistance in the past 3 month

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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.

  PMID: 35317789 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Damon Vidrine
• Organization: Moffitt Cancer Center

Damon.Vidrine@moffitt.org

813-745-7937

Study Officials

• Damon J Vidrine, Dr.PH

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Jennifer I Vidrine, Ph.D.

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: December 1, 2021
• Primary Completion: June 5, 2025
• Study Completion: August 19, 2025
• Last Updated: August 4, 2026
• Results First Posted: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)