Smartphones for Opioid Addiction Recovery (SOAR)

This study is testing a smartphone app called SOAR (Smartphones for Opioid Addiction Recovery) to help people with opioid-use disorder. The app aims to reduce how often people use illicit opioids while they are receiving treatment with methadone or buprenorphine. Researchers want to see if using the SOAR app to adjust medication doses can lead to fewer instances of illicit opioid use compared to standard care. You may be able to join if you are 18 years or older, have opioid-use disorder, and are starting or planning to start a treatment program with methadone or buprenorphine. The study is currently recruiting 225 participants.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 225 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at 1 month, 3 months, and 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05033028

Smartphones for Opiate Addiction Recovery

Recruiting
PHASE3Ages 18–85InterventionalTreatment
NYU Langone Health
~225 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Smartphone app

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).
Measured over 1 month visit, 3 months visit, 6 months visit
Opioid-use Disorder
2 sites across 2 states
New Jersey1
New York1
  • Stephen Ross, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids);
Have entered, or expressed a clear intention to enter, an OUD treatment program that prescribes either methadone or buprenorphine
Any gender;
18 years of age and older;
Have used opioids other than as specifically prescribed within thirty days prior to consent;
In good-enough general health;
Capacity to provide written informed consent as assessed by our Subject Comprehension Assessment Tool(subjects lacking the ability to consent will not be enrolled) ;
Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
Licensed MD employed by the respective site, or at a clinical partner of the respective site, where they will act as participants and be part of the treatment team
Currently practicing in the treatment of OUD with either Buprenorphine or Methadone;
Able to speak, read, and write English fluently and to provide informed consent in English
Licensed MSW, NP, or MD; who are not part of any treatment team within the study and may be employees of their respective sites or other treatment facilities.
Currently practicing in the treatment of OUD with either Buprenorphine or Methadone;
Able to speak, read, and write English fluently and to provide informed consent in English

Exclusion

Serious medical, psychiatric or non-opioid substance use disorder that, in the opinion of a study physician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study. Examples include: (a) Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included);
Suicidal or homicidal ideation that requires immediate attention;
Presence of pain of sufficient severity as to require ongoing pain management with opioids;
Pending legal action or other reasons that might prevent an individual from completing the study.
Pregnancy as assessed by urine pregnancy testing
Breastfeeding of infants, as assessed by self-report.
Prisoners, as defined by OHRP, are excluded from participation in the study.
Individuals receiving residential court-ordered substance abuse treatment.
none
none
  • Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).1 month visit, 3 months visit, 6 months visit

    This is measured by collecting one salivary drug test every two weeks in addition to any drug testing they may complete as part of their clinical treatment. Once saliva samples are obtained they will be aggregated and sent weekly for analysis by mass spectrometry. The primary outcome from these data will be the number of toxicology tests positive for illicit opioids. These data are count in nature and truncated at both 0 and 12.