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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month visit, 3 months visit, 6 months visit
Awards & highlights
SOAR Trial 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.
SOAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
SOAR Trial 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
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
SOAR 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
1,368 Previous Clinical Trials
839,216 Total Patients Enrolled
John Rotrosen, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
3,011 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am in or plan to join a treatment program for opioid use that includes methadone or buprenorphine.I am a clinician currently treating OUD with Buprenorphine or Methadone.I am in good general health.My gender does not affect my eligibility.I understand and can sign the consent form for the trial.I need opioids to manage my severe pain.Your doctor must work for the clinical site or be a clinical partner of the site where you will receive treatment.I am a physician currently treating opioid use disorder with Buprenorphine or Methadone.I am 18 years old or older.I am 18 years old or older.My gender does not affect my eligibility.You are generally healthy enough to participate in the trial.You have taken opioids for non-medical reasons within the last 30 days before agreeing to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Focus group with Study Physicans
- Group 2: Treatment-as-Usual
- Group 3: Smartphone with dose changes before using
- Group 4: Focus group with Clinicians
- Group 5: Smartphone with dose changes after using
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being recruited for this research at present?
"According to the clinicaltrials.gov repository, this medical trial is in its recruitment phase. It was first announced on December 31st 2021 and recently revised on June 7th 2022."
Answered by AI
How many patients is this clinical trial recruiting?
"Affirmative, clinicaltrials.gov reveals that this research study is actively recruiting patients and was originally published on December 31st 2021. The medical trial seeks to enrol 510 participants from two distinct sites with the last update taking place on June 7th 2022."
Answered by AI
Do I meet the prerequisites to join this research endeavor?
"To qualify for this trial, potential participants must have a history of opiod addiction and be between 18-85 years old. The medical study plans to enroll around 510 individuals."
Answered by AI
Are octogenarians accepted into this research study?
"The entrance requirements for this trial mandate that participants must be 18 years or older, yet not exceed 85 years of age."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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