Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that is active but no longer recruiting, run by University of Oklahoma. The registered enrollment target is 64 participants.
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-
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04887558
The ClinicalTrials.gov registry entry for NCT04887558 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Smart-T Mental Health and NRT is the first listed.
NCT04887558 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.