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OpenTrials
Completed

NCT Number: NCT05004662

Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Receipt of food assistance in the past 3 month

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

Treatment and study plan

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

Nicotine patch

Drug

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

Counseling

Behavioral

Smoking cessation treatment delivery by State Quitline's

Nicotine Lozenge

Drug

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

Primary outcomes

  1. Self-Reported 7-Day Point-Prevalence Smoking Abstinence

    Time frame: 12 Month Follow-Up

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

Secondary outcomes

  1. Biochemical Verification Via Salivary Cotinine

    Time frame: 12 Month Follow-Up

    Investigators will biochemically verify smoking status by collecting cotinine samples via salivary cotinine kit

  2. Self-Reported 24-Hour Point-Prevalence Smoking Abstinence

    Time frame: 12 Month Follow-Up

    Number of participants who report no smoking, not even a puff, within the past 24 hours

  3. Self-Reported 30-Day Point-Prevalence Smoking Abstinence

    Time frame: 12 Month Follow-Up

    Number of participants who report no smoking, not even a puff, within the past 30 days

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2021
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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