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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 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.

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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

Conditions Studied

Alcohol Misuse Homeless

Interventions

  • OTHER Usual Care
  • OTHER Smart-T Alcohol

Study Locations (1)

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2025-03-05
Est. Completion 2029-04-30
Phase Phase 2

Sponsor

University of Oklahoma

358 total trials

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What the Registry Record Tells You About NCT06821295

The ClinicalTrials.gov registry entry for NCT06821295 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,549-participant average among 8 other Alcohol Misuse trials with a reported enrollment target (61% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.