Smoking CessationNCT05004662
Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers
A study testing Smartphone-delivered automated treatment, Nicotine patch and Counseling in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study evaluates the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smartphone-delivered automated treatment, Nicotine patch and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 19 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Partnering With a State Food Bank to Provide Tobacco Treatment to Underserved Smokers (Project NOURISH)
This study evaluates the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.
- Conditions
- Smoking Cessation
- Being tested
- Smartphone-delivered automated treatment, Nicotine patch, Counseling, Nicotine lozenge
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-delivered automated treatmentBehavioural
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 patchDrug
Participants were provided with a 10-week supply of nicotine patches
CounselingBehavioural
Smoking cessation treatment delivery by State Quitline's
Nicotine lozengeDrug
Participants were provided with a 10-week supply of nicotine lozenges
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Participants randomized to Standard Treatment (ST) were provided with a 10-week supply of nicotine patches and lozenges. ST participants were connected with their state's Quitline services to receive smoking cessation treatment. Receives: Drug: Nicotine patch; Behavioral: Counseling; Drug: Nicotine lozenge |
| Automated Treatment | Experimental | Participants randomized to Automated Treatment (AT) were given a 10-week supply of nicotine patches and lozenges. AT comprised: 1) 12 proactive video-based treatment sessions, delivered weekly, that were tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content. Receives: Behavioral: Smartphone-delivered automated treatment; Drug: Nicotine patch; Drug: Nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
Participants who report no smoking, not even a puff, within the past 7 days
Measured: 12 Month Follow-Up
Secondary outcomes (3)
Biochemical Verification Via Salivary Cotinine
Investigators will biochemically verify smoking status by collecting cotinine samples via salivary cotinine kit
Measured: 12 Month Follow-Up
Self-Reported 24-Hour Point-Prevalence Smoking Abstinence
Number of participants who report no smoking, not even a puff, within the past 24 hours
Measured: 12 Month Follow-Up
Self-Reported 30-Day Point-Prevalence Smoking Abstinence
Number of participants who report no smoking, not even a puff, within the past 30 days
Measured: 12 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Dec 2021
- Primary completion5 Jun 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Damon J Vidrine, Dr.PH, Principal investigator, Moffitt Cancer CenterJennifer I Vidrine, Ph.D., Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004662
- Sponsor's protocol ID
- MCC-20154
- Other IDs
- R01CA231952
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2021
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35317789