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Behavioural Intervention

Smartphone App for Opioid Addiction Recovery (SOAR Trial)

N/A

Recruiting

Led By John Rotrosen, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Clinician Participants must be currently practicing in the treatment of OUD with either Buprenorphine or Methadone

Patients must have the capacity to provide written informed consent as assessed by the Subject Comprehension Assessment Tool (subjects lacking the ability to consent will not be enrolled)

Must not have

Patients with pain of sufficient severity as to require ongoing pain management with opioids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month visit, 3 months visit, 6 months visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to help people with addiction by using a 5-minute battery to help predict if they will use illicit opiates in the next 7-10 days.

Who is the study for?

This trial is for adults with opioid-use disorder who are entering or planning to enter a treatment program using methadone or buprenorphine. Participants must be in stable health, able to understand and consent to the study in English, and have used opioids recently. Excluded are those with severe pain requiring opioids, pregnant or breastfeeding women, prisoners, individuals under court-ordered treatment, and those with serious medical or mental conditions.

What is being tested?

The trial is testing a smartphone app designed to predict the likelihood of illicit opiate use within the next week among patients undergoing addiction treatment. The goal is to reduce illicit opiate use during recovery by providing timely interventions based on these predictions.

What are the potential side effects?

Since this intervention involves a smartphone app rather than medication, traditional side effects associated with drugs do not apply. However, participants may experience stress or anxiety related to monitoring their potential for relapse.

Eligibility Criteria

Inclusion Criteria

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

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I am a clinician currently treating OUD with Buprenorphine or Methadone.

Select...

I understand and can sign the consent form for the trial.

Select...

I am a physician currently treating opioid use disorder with Buprenorphine or Methadone.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I need opioids to manage my severe pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month visit, 3 months visit, 6 months visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month visit, 3 months visit, 6 months visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month visit, 3 months visit, 6 months visit for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).

Secondary study objectives

To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Smartphone with dose changes before usingExperimental Treatment1 Intervention

Participants will have an app installed on their phone and have to complete a brief questionnaire and some days to play a 2-4 minute game.

Group II: Smartphone with dose changes after usingExperimental Treatment1 Intervention

Participants will have an app installed on their phone and have to complete a brief questionnaire and some days play a 2-4 minute game.

Group III: Focus group with Study PhysicansExperimental Treatment1 Intervention

Study physicians asked to participate in a focus group session or 1:1 interviews if unable to attend the focus group during year one of the study and once annually towards the end of years 2, 3, 4, and 5 of the study

Group IV: Focus group with CliniciansExperimental Treatment1 Intervention

Clinicians asked to participate in a 1:1 interview and a separate focus group at roughly the same time. Prior to the first structured interview with our study team, you will participate in a 1-hour training and familiarization session with the SOAR system using synthetic or training data.

Group V: Treatment-as-UsualActive Control1 Intervention

Participants will receive the same treatment as if they had not joined the study

0 / 5Eligibility criteria met