Recruiting
Phase 3

Smartphones

Sponsor:

NYU Langone Health

Code:

NCT05033028

Conditions

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Smartphone app

Study Details

Brief summary:

Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can be high, and reducing illicit opiate use during treatment has thus recently become a major NIDA policy goal. The 5-minute battery indicates the numerical probability that a patient will reuse illicit opiates within the next 7-10 days.

Conditions

Opioid-use Disorder

Study ID

NCT05033028

Start date

Nov 1, 2021

Status verified date

Jun, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients:

  • 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.

Study-Physician Participants.

  • 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

Clinician Participants.

  • 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 Criteria:

Patients:

  • 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.

Study-Physician Participants.

  • none

Clinician Participants.

  • none

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Treatment-as-Usual

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

experimental: Smartphone with dose changes after using

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.

experimental: Smartphone with dose changes before using

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.

experimental: Focus group with Study Physicans

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

experimental: Focus group with Clinicians

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.

Interventions

Smartphone app

SOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout.

Primary outcome measure

  • Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU). [ Time Frame: 1 month visit, 3 months visit, 6 months visit ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Stephen Ross, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-23.