NCT05004662

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

August 6, 2021

Last Update Submit

March 24, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Self Reported 7 Day Abstinence Smoking Status

    Participants will self report 7-day abstinence smoking status

    12 Month Follow-Up

Secondary Outcomes (4)

  • Smoking Status by Saliva Cotinine Kit

    12 Month Follow-Up

  • Self Reported 24 Hours Smoking Abstinence

    12 Month Follow-Up

  • 30 Day Smoking Abstinence

    12 Month Follow-Up

  • Continuous 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 patchBehavioral: CouncelingDrug: 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/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content

Behavioral: Smartphone-delivered automated treatmentDrug: Nicotine patchDrug: Nicotine lozenge

Interventions

Smartphone-delivered automated treatmentBEHAVIORAL

An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant

Automated Treatment
Nicotine patchDRUG

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

Automated TreatmentStandard Treatment
CouncelingBEHAVIORAL

Phone counseling with the Florida Quitline

Standard Treatment
Nicotine lozengeDRUG

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

Automated TreatmentStandard Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 35317789DERIVED

Related Links

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Damon J Vidrine, Dr.PH

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

  • Jennifer I Vidrine, Ph.D.

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

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

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)