Smartphone App for Alcoholism in Homeless Adults

(SmartT_A Trial)

Overseen By Michael Businelle, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Oklahoma

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app designed to help reduce alcohol use among adults experiencing homelessness. Participants will receive either the usual care available at shelters or the usual care plus access to the Smart-T Alcohol app, which provides on-demand tips and sends personalized messages to support reducing alcohol consumption. The goal is to determine if the app can effectively lower alcohol use and related problems. Individuals currently using shelters, who have reported recent alcohol consumption, and possess certain reading and cognitive abilities (as assessed by simple tests) might be a good fit for this trial. As a Phase 2, Phase 3 trial, this study measures the app's effectiveness in an initial group and represents the final step before potential approval, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that the Smart-T Alcohol intervention is likely to be safe?

Research has shown that the Smart-T Alcohol app has been generally well-received by users in past studies. Over four weeks, participants using the app reported positive results in managing their alcohol use without major side effects. The app sends personalized messages to help control drinking, and feedback suggests it is safe to use.

The trial is in a later phase, indicating that earlier trials have already provided some evidence supporting its safety. This stage usually focuses on effectiveness, so major safety concerns are not expected. Participants in previous trials used the app successfully, and no serious safety issues were reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Smart-T Alcohol app because it offers a novel approach to managing alcoholism in homeless adults, integrating technology with traditional care. Unlike standard treatments such as 12-step programs or outpatient services, Smart-T Alcohol uses a smartphone app to provide personalized support. It features an on-demand "Tips" function and an algorithm that tailors messages based on daily survey responses, helping users stay on track with their drinking goals. This tech-driven method could enhance accessibility and responsiveness, offering immediate, customized support that adapts to each individual's needs.

What evidence suggests that the Smart-T Alcohol intervention might be an effective treatment for alcohol use disorder in homeless adults?

This trial will compare the effectiveness of usual care alone with usual care plus the Smart-T Alcohol app in reducing alcohol use among adults who are homeless. Research has shown that the Smart-T Alcohol app can help reduce alcohol use, as users improved their drinking habits over four weeks. The app provides tips and sends personalized messages to manage alcohol use. It adjusts its advice based on daily surveys, helping users meet their drinking goals. Early results suggest this method can enhance treatment involvement and improve the quality of life for those with alcohol use issues. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are experiencing homelessness, have an alcohol use disorder, and are currently receiving shelter-based services. Participants must be able to read at a basic level, have no significant cognitive impairment, and have consumed alcohol in the past week.

Inclusion Criteria

My cognitive test score is below 8.

Scoring 8 or above on the AUDIT

Receiving shelter-based services

Exclusion Criteria

Not meeting other inclusion criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Training and Baseline Monitoring

Participants receive training on the smartphone-based assessment platform and complete daily EMAs for baseline data collection

1 week

Daily EMAs

Treatment

Participants receive either Usual Care or Usual Care plus the Smart-T Alcohol intervention for alcohol use reduction

8 weeks

Daily EMAs

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments

17 weeks

Assessments at weeks 9, 13, and 26

What Are the Treatments Tested in This Trial?

Interventions

• Smart-T Alcohol

Trial Overview The study tests if a smartphone app called Smart-T Alcohol can help reduce drinking when added to usual care in shelters. It sends tailored messages and content on-demand. The trial will compare results from this approach with those just receiving standard treatment.

How Is the Trial Designed?

Group I: Usual Care + Smart-T Alcohol Experimental Treatment 2 Interventions

The Smart-T Alcohol arm will receive Usual Care plus the Smart-T Alcohol smartphone-based intervention which includes two core components: 1) an on-demand "Tips" function/button; and 2) an algorithm that uses daily survey responses to assess current risk for alcohol use and automatically delivers tailored messages to help participants achieve their daily drinking goal.

Group II: Usual Care (UC) Active Control 1 Intervention

All participants at the recruitment sites have access to 12-step support groups, intensive or supportive outpatient services, and/or medical and/or psychiatric care. All participants that report heavy drinking episode(s) during daily smartphone-based surveys will be referred for additional treatment services via a designated shelter referral/contact.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9509425/

Development and preliminary effectiveness of a ... This paper summarizes alcohol use outcomes among adults experiencing homelessness while they were using the Smart-T Alcohol JITAI. Over 4 weeks, participants ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03746808

Development and Testing of a Just-in-Time Adaptive Smart ... If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with AUDs. This ...

3. unthsc.edu unthsc.edu/college-of-public-health/new-smartphone-app-study-demonstrates-success-in-improving-alcohol-treatment-quality-of-life-for-homeless-adults/

New smartphone study demonstrates success in alcohol ... New smartphone app study demonstrates success in improving alcohol treatment, quality of life for adults experiencing homelessness. October 12, ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/574956

Efficacy of a Smartphone-Based JITAI to Reduce Drinking ... The Smart-T Alcohol intervention offers on-demand content and automated contextually tailored messages to reduce alcohol consumption. The intervention period ...

5. ouhealth.com ouhealth.com/blog/2022/august/smartphone-app-reduces-alcohol-misuse-in-adults-/

Smartphone App Reduces Alcohol Misuse in Adults ... The Smart-T Alcohol app delivers tailored treatment messages based on current drinking goals and drinking risk factors. Over the 28-day ...

6. withpower.com withpower.com/trial/phase-2-and-3-alcohol-misuse-1-2025-1edde

Smartphone App for Alcoholism in Homeless Adults This trial is for adults over 18 who are experiencing homelessness, have an alcohol use disorder, and are currently receiving shelter-based services.