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Phase 3 N=454 Randomized Treatment

Smartphone Based Smoking Cessation Intervention

Smoking Cessation

Enrolled (actual)
454
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Biochemically-Verified Smoking Cessation — 37; 23 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Smart-T + NRT (Combination_product); QuitGuide + NRT (Combination_product)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Oklahoma
Primary completion
Nov 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Biochemically-Verified Smoking Cessation
37; 23
SECONDARY
Change in Urge to Quit Smoking
0.053; 0.017 0.284
SECONDARY
Change in Stress
-0.005; -0.031 0.477
SECONDARY
Change in Perceived Cigarette Availability
0.011; -0.010 0.456
SECONDARY
Change in Motivation to Quit Smoking
-0.005; -0.002 0.215

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • cannot read, speak, and understand English
  • are < 18 years of age
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03740490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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