Opioid-use DisorderPhase 3SOARNCT05033028
Smartphones for Opiate Addiction Recovery
A Phase 3 study testing Smartphone app in people with Opioid-use Disorder, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Smartphone app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2021to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 17Show fewer
- 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
Who cannot join
- 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;
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone
New York, New York, 10016
Paul Glimcher, 212-263-8167, paul.glimcher@nyulangone.org
Stephen Ross, MD
- Not yet recruiting
Rutgers University
Piscataway, New Jersey, 08854
Anna Konova, MD, 929-390-8905, anna.konova@rutgers.edu
Anna Konova, MD
About this study
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.
Read the detailed description
The primary goal in this mid-scale clinical trial is to test the hypothesis that clinicians who use the output of the mobile system to adjust buprenorphine and methadone dosing achieve lower opiate reuse rates than physicians who provide care-as-usual. The secondary goal is to examine the usability and desirability of this solution for clinicians with an eye to usability and large-scale deployment. The third and final goal is to measure the cost-effectiveness of this solution from multiple perspectives. If successful it will be possible to employ an algorithmic and measurement-based approach to OUD treatment with methadone and buprenorphine which reduces reuse rates and relapse rates amongst OUD patients.
- Conditions
- Opioid-use Disorder
- Being tested
- Smartphone app
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone appOther
SOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. Receives: Other: Smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
This will be measured through self reports through the smartphone and assessed by randomly scheduled, remote drug screens with saliva samples.
Measured: 1 month visit, 3 months visit, 6 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Ross, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033028
- Sponsor's protocol ID
- 21-00340
- Acronym
- SOAR
- Status last verified
- Jun 2026
- First submitted
- 27 Aug 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphones for Opiate Addiction Recovery
- ClinicalTrials.gov ID
- NCT05033028
- Acronym / sponsor ID
- SOAR / 21-00340
- Conditions
- Opioid-use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary goal in this mid-scale clinical trial is to test the hypothesis that clinicians who use the output of the mobile system to adjust buprenorphine and methadone dosing achieve lower opiate reuse rates than physicians who provide care-as-usual. The secondary goal is to examine the usability and desirability of this solution for clinicians with an eye to usability and large-scale deployment. The third and final goal is to measure the cost-effectiveness of this solution from multiple perspectives. If successful it will be possible to employ an algorithmic and measurement-based approach to OUD treatment with methadone and buprenorphine which reduces reuse rates and relapse rates amongst OUD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Smartphone appParticipants will have an app installed on their phone and have to complete a brief questionnaire and some days play a 2-4 minute game. |
| Smartphone with dose changes before using | Experimental | Other: Smartphone appParticipants 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. |
| Focus group with Study Physicans | Experimental | Other: Smartphone appStudy 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 |
| Focus group with Clinicians | Experimental | Other: Smartphone appClinicians 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone appSOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout. | Other | Focus group with Clinicians, Focus group with Study Physicans, Smartphone with dose changes after using, Smartphone with dose changes before using |
Primary outcome
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
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 secondary outcome
To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU
Time frame: 1 month visit, 3 months visit, 6 months visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Opioid-use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Ross, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Smartphone app in people with Opioid-use Disorder, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Glimcher (212-263-8167, Paul.glimcher@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.