Smartphones for Opiate Addiction Recovery

NCT05033028 | Recruiting Phase 3 DMC

• 1 other identifier: 21-00340
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 month visit, 3 months visit, 6 months visit

Secondary Outcomes (1)

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

  1 month visit, 3 months visit, 6 months visit

Study Arms (5)

Treatment-as-Usual

NO INTERVENTION

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

Smartphone with dose changes after using

EXPERIMENTAL

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.

Other: Smartphone app

Smartphone with dose changes before using

EXPERIMENTAL

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.

Other: Smartphone app

Focus group with Study Physicans

EXPERIMENTAL

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

Other: Smartphone app

Focus group with Clinicians

EXPERIMENTAL

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.

Other: Smartphone app

Interventions

Smartphone app OTHER

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

Focus group with Clinicians; Focus group with Study Physicans; Smartphone with dose changes after using; Smartphone with dose changes before using

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

Rutgers University

Piscataway, New Jersey, 08854, United States

NOT YET RECRUITING

NYU Langone

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Stephen Ross, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Glimcher

CONTACT

212-263-8167; Paul.glimcher@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Researchers who provide a methodologically sound proposal. Upon reasonable request. Requests should be directed to Paul.glimcher@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)