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Smartphone Apps for Opioid Use Disorder

Phase 2

Waitlist Available

Led By Andrew James, Ph.D.

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 18 years and older

Be older than 18 years old

Must not have

(MRI) Medical history: A history of neurological, cardiovascular, or infectious disease would exclude study participation. A loss of consciousness of 20 or more min or other evidence of brain trauma also would be exclusionary.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial would use apps to help prevent relapse among patients receiving treatment for opioid use disorder. The apps would track the person's location and offer targeted, personalized intervention when they enter an area at high risk for relapse.

Who is the study for?

Adults over 18 with opioid use disorder in early phase medication-assisted treatment can join. For the MRI study, participants must be 18-50 years old, native English speakers, and not pregnant or have certain medical conditions. They should agree to use a smartphone for the intervention.

What is being tested?

The trial tests if smartphone apps can help prevent relapse in opioid addiction by monitoring drug use and providing feedback. It includes location-tracking for real-time support in high-risk areas and uses MRI scans to study brain changes linked to treatment success.

What are the potential side effects?

There are no direct side effects mentioned from using the smartphone app intervention itself; however, participation involves MRI scanning which may not be suitable for all due to various contraindications like claustrophobia or presence of metal implants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of serious neurological, heart diseases, infections, or significant brain injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinalysis - Week 0 (Intake)

Urinalysis - Week 1

Urinalysis - Week 10

+24 more

Secondary study objectives

TLFB - Month 0 (Intake)

TLFB - Month 1

TLFB - Month 2

+30 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SmartphoneExperimental Treatment1 Intervention

Participants randomized into the Smartphone app arm would use the smartphone app OptiMAT in conjunction with treatment as usual (TAU). Participants would use OptiMAT to complete daily self-assessments of opiate misuse, opiate craving, opiate withdrawal, and mood. The app will personalized feedback for maintaining abstinence goals. The app would also use geographic ecological momentary assessment (GEMA) to intervene via push notification when participants enter areas previously identified as high-risk for opiate use.

Group II: Monitoring OnlyActive Control1 Intervention

Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Smartphone

2016

Completed Early Phase 1

~1740

0 / 2Eligibility criteria met