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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

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.Check my eligibility
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.See study design
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
Select...
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).
Secondary outcome measures
To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU

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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,608 Total Patients Enrolled
John Rotrosen, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
3,011 Total Patients Enrolled

Media Library

Smartphones for Opiate Addiction Recovery (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05033028 — N/A
Opioid Use Disorder Research Study Groups: Focus group with Study Physicans, Treatment-as-Usual, Smartphone with dose changes before using, Focus group with Clinicians, Smartphone with dose changes after using
Opioid Use Disorder Clinical Trial 2023: Smartphones for Opiate Addiction Recovery Highlights & Side Effects. Trial Name: NCT05033028 — N/A
Smartphones for Opiate Addiction Recovery (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05033028 — N/A
~184 spots leftby Jan 2026