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NCT06821295 · ClinicalTrials.gov registry record · Phase 2
Efficacy of a Smartphone-Based JITAI to Reduce Drinking Among Adults Experiencing Homelessness
A Phase 2 study of Alcohol Misuse and Homeless, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 1
- Study location
NCT06821295: Recruiting Phase 2 study of Alcohol Misuse and Homeless, sponsored by University of Oklahoma.
NCT06821295 is a Phase 2 study of Alcohol Misuse and Homeless that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 600 participants, below the 1,549-participant average among 8 other Alcohol Misuse trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06821295, a Phase 2 study of Alcohol Misuse and Homeless, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 1
- Study location
Study Summary
Approximately 1 out of every 3 adults experiencing homelessness has a current alcohol use disorder (AUD). Alcohol use plays a central role in increased morbidity and mortality in this population, with some studies suggesting it plays a direct role in as many as 17% of deaths. Alcohol is also a leading cause of homelessness and contributes to its chronicity by inhibiting progress toward obtaining employment and a stable living environment. Shelter-based treatments are common, but compliance is often poor. There are many documented challenges to effectively implementing traditional evidence-based interventions in shelter settings. In the current project, we will conduct a randomized controlled trial. Adults currently experiencing homelessness who report hazardous alcohol use (N = 600) will be recruited from five shelters across the Dallas, TX and Oklahoma City, OK metropolitan areas. Individuals will attend screening and training visits, then complete one week of self-monitoring (via smartphone app) before being randomized to receive either standard shelter-based treatment (Usual Care; UC), or the Smart-T Alcohol intervention + UC. The Smart-T Alcohol intervention offers on-demand content and automated contextually tailored messages to reduce alcohol consumption. The intervention period will span eight-weeks (i.e., weeks 2-9), with follow-up assessments occurring at weeks 9, 13, and 26. All participants will complete brief daily smartphone-based surveys for 13 weeks. Aims of the project will be to assess the effects of the Smart-T Alcohol intervention on alcohol use and alcohol-related problems (Aim 1), intervention effects on key drinking risk indicators and their mediation of use outcomes (Aim 2), and identify specific subpopulations (e.g., women, racial/ethnic minorities, younger adults; Exploratory Aim 3) for which the intervention is most effective. Findings will provide a rigorous evaluation of the efficacy of the Smart-T Alcohol intervention and guide future sm
Primary Outcome
The number of drinks per week reported during daily EMAs.
Conditions Studied
Interventions
- OTHER Usual Care
- OTHER Smart-T Alcohol
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 2 |
What NCT06821295 shows while recruiting
NCT06821295 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 1,549-participant average among 8 other Alcohol Misuse trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Alcohol Misuse appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT06821295 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT06821295 about?
NCT06821295 is a clinical study titled "Efficacy of a Smartphone-Based JITAI to Reduce Drinking Among Adults Experiencing Homelessness". Approximately 1 out of every 3 adults experiencing homelessness has a current alcohol use disorder (AUD). Alcohol use plays a central role in increased morbidity and mortality in this population, with some studies suggesting it plays a direct role in as many as 17% of deaths. Alcohol is also a leadi...
What is the current status of trial NCT06821295?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2025-03-05. Estimated completion is 2029-04-30.
What conditions does trial NCT06821295 study?
This clinical trial studies the following conditions: Alcohol Misuse, Homeless.
What interventions are being tested in trial NCT06821295?
The interventions under investigation include: Usual Care (OTHER), Smart-T Alcohol (OTHER).
Who is sponsoring clinical trial NCT06821295?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06821295 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06821295's enrollment target sits among peer trials
600 3rd of 8 higher than 6 of 8 other Alcohol Misuse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Misuse 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.
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