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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
Sex: male or female
In Phase I treatment of MAT for opioid-use disorder. (Phase I indicates that patient is receiving no more than one week of take-home medications at each weekly clinic visit.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 either male or female.
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I am in the initial phase of treatment for opioid addiction, receiving weekly medication.
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I am 18 years old or older.
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I am 18 years old or older.
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I am willing to use a smartphone for the study if needed.
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I am between 18 and 50 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinalysis - Week 0 (Intake)
Urinalysis - Week 1
Urinalysis - Week 10
+24 more
Secondary outcome measures
TLFB - Month 0 (Intake)
TLFB - Month 1
TLFB - Month 2
+30 more

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

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
483 Previous Clinical Trials
148,272 Total Patients Enrolled
Andrew James, Ph.D.Principal InvestigatorUniversity of Arkansas

Media Library

Smartphone Clinical Trial Eligibility Overview. Trial Name: NCT05336188 — Phase 2
Opioid Use Disorder Research Study Groups: Smartphone, Monitoring Only
Opioid Use Disorder Clinical Trial 2023: Smartphone Highlights & Side Effects. Trial Name: NCT05336188 — Phase 2
Smartphone 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336188 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental protocol currently enrolling participants?

"The information found on clinicaltrials.gov suggests that this particular trial, which was initially posted in November 2022 and updated last month, is not recruiting patients currently. However, there are 347 other studies actively looking for participants presently."

Answered by AI

What risks do individuals face when utilizing smartphones?

"While the efficacy of Smartphone is yet to be determined, prior clinical data suggests that it's safety rating should stand at 2 on our scale."

Answered by AI

What is the ultimate aim of this research?

"The primary objective to be observed over roughly 23 weeks is a urinalysis at intake. Secondary aims include the TLFB - Month 6, which assesses how many days in the past month there has been self-reported opioid misuse, Treatment Continuation - Week 8 and 16 binary variables indicating if patients are still receiving treatment or not, with survival analysis employed to determine whether duration of treatment differs by study arm."

Answered by AI

Who else is applying?

What state do they live in?
Washington
West Virginia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Brain Imaging Research Center
~170 spots leftby Sep 2027