Smartphone Based Smoking Cessation Intervention

NCT03740490 | Completed Phase 2 Results

• 2 other identifiers: 9860R01CA221819
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking is becoming increasingly concentrated among individuals with the lowest levels of income, education, and occupational status. In fact, smoking rates in the United States among people living below the poverty line is nearly twice as high as those above the poverty threshold. Highly flexible and low burden technology-based treatment approaches may overcome many of the barriers that have limited the use and effectiveness of traditional smoking cessation treatments among low socioeconomic status (SES) adults. Ecological momentary assessment (EMA), in which mobile devices are used to capture moment-to-moment experiences, allows for the measurement of phenomena in real-time within natural settings. Smartphone-based smoking cessation apps could offer easily accessible, highly tailored, and intensive interventions at a fraction of the cost of traditional smoking cessation counseling. The Smart-T app uses a lapse risk estimator to identify moments of heightened risk for lapse, and the algorithm tailors treatment messages in real-time based upon level of imminent smoking lapse risk and currently present lapse triggers. This study will compare smoking cessation rates for those randomized to the Smart-T app or the NCI QuitGuide app.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Smartphone Based Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Biochemically-Verified Smoking Cessation

  Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 6 ppm

  27 Weeks

Secondary Outcomes (4)

• Change in Urge to Quit Smoking

  27 weeks

• Change in Stress

  27 weeks

• Change in Perceived Cigarette Availability

  27 weeks

• Change in Motivation to Quit Smoking

  27 weeks

Study Arms (2)

Smart-T + NRT

EXPERIMENTAL

Smart-T provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free nicotine replacement therapy (NRT).

Combination Product: Smart-T + NRT

NCI QuitGuide + NRT

ACTIVE COMPARATOR

The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free nicotine replacement therapy (NRT).

Combination Product: QuitGuide + NRT

Interventions

Smart-T + NRT COMBINATION_PRODUCT

Smart-Treatment App and Nicotine Replacement Therapy

Smart-T + NRT

QuitGuide + NRT COMBINATION_PRODUCT

NCI QuitGuide Treatment App and Nicotine Replacement Therapy

NCI QuitGuide + NRT

Eligibility Criteria

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

You may qualify if:

• earn a score ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) indicating \> 6th grade English literacy level
• are willing to quit smoking 7 days after the baseline visit
• are ≥ 18 years of age
• have an expired CO level ≥ 8 ppm suggestive of current smoking
• are currently smoking ≥ 5 cigarettes per day
• have no contraindications to using nicotine replacement therapy (NRT)
• agree to complete EMAs and CO tests on a study provided or personal smartphone
• have household income \< 200% of the federal poverty guideline
• agree to complete the 26 week post-quit follow-up assessment over the phone and via EMA

You may not qualify if:

• cannot read, speak, and understand English
• are \< 18 years of age

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center - HPRC

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Hebert ET, Kendzor DE, Vidrine DJ, Langford JS, Kezbers KM, Montgomery A, Chen M, Frank-Pearce SG, Vesely SK, Chen S, Barrett ZCW, Businelle MS. Just-in-Time Adaptive Intervention for Smoking Cessation in Low-Income Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2526691. doi: 10.1001/jamanetworkopen.2025.26691.

  PMID: 40810943 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Michael Businelle
• Organization: Stephenson Cancer Center, University of Oklahoma Health Sciences

michael-businelle@ouhsc.edu

405-271-8001

Study Officials

• Michael S Businelle, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: August 26, 2019
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: August 17, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)