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NCT04887558 · ClinicalTrials.gov registry record · Phase 2
Mobile App for Smoking Cessation and Mental Health
A Phase 2 study, sponsored by University of Oklahoma.
- Active
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT04887558: Active Phase 2 study, sponsored by University of Oklahoma.
NCT04887558 is a Phase 2 study that is active but no longer recruiting, run by University of Oklahoma. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04887558, a Phase 2 study, is active but no longer recruiting, sponsored by University of Oklahoma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Adults with serious mental illness (SMI) represent 5% of the United States population, yet account for 30% of all cigarettes smoked and are 2 to 3 times more likely to be dependent on nicotine compared with the general population. There are also significant disparities in quitting: 24% of lifetime smokers with SMI report not smoking within the past year compared with 52% of lifetime smokers without SMI. Two barriers partly explain the large disparity in smoking cessation rates between adults with and without SMI. First, there is a lack of high-quality, evidence-based interventions for smoking cessation in populations with SMI, which may be because adults with SMI are often excluded from clinical trials, despite evidence indicating that SMI is highly comorbid with smoking. Second, clinicians and staff within mental health settings generally do not have the resources or appropriate training to provide smoking cessation treatments to patients with SMI. Smartphone-based mobile health applications for smoking cessation could significantly improve cessation rates for adults with SMI. However, smoking cessation apps are underutilized by smokers with SMI partly because the apps are not designed for their unique needs. This study aims to conduct a pilot randomized controlled trial to evaluate the feasibility of an innovative, evidence-based smoking cessation app tailored for smokers with SMI. Seventy-five treatment-seeking smokers with SMI who will be referred from the Oklahoma Department of Mental Health and Substance Abuse Services (25 per group), a publicly funded outpatient psychiatry treatment program, will be randomly assigned to receive either (1) QuitGuide, a free smoking cessation app developed by the National Cancer Institute, (2) a smoking cessation app that tracks and automatically intervenes upon psychological distress during a quit attempt and delivers real-time intervention messages tailored to the current level of lapse risk and current lapse triggers (Smart-
Primary Outcome
Biochemically confirmed 7-day point prevalence abstinence using the CO criteria cutoff of ≤ 7 ppm
Interventions
- COMBINATION_PRODUCT Smart-T Mental Health and NRT
- COMBINATION_PRODUCT Smart-T Mental Health+ and NRT
- COMBINATION_PRODUCT QuitGuide + NRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What the registry record for NCT04887558 still lists
NCT04887558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Smart-T Mental Health and NRT is the first listed.
NCT04887558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04887558 about?
NCT04887558 is a clinical study titled "Mobile App for Smoking Cessation and Mental Health". Adults with serious mental illness (SMI) represent 5% of the United States population, yet account for 30% of all cigarettes smoked and are 2 to 3 times more likely to be dependent on nicotine compared with the general population. There are also significant disparities in quitting: 24% of lifetime s...
What is the current status of trial NCT04887558?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2021-12-14. Estimated completion is 2028-12.
What interventions are being tested in trial NCT04887558?
The interventions under investigation include: Smart-T Mental Health and NRT (COMBINATION_PRODUCT), Smart-T Mental Health+ and NRT (COMBINATION_PRODUCT), QuitGuide + NRT (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04887558?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04887558's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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