Phone app predicts relapse to stop opioid abuse during treatment

NCT ID NCT05033028

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a smartphone app can help people reduce their use of illegal opioids while they are in treatment for opioid addiction. The app uses a short test to predict the chance of relapse in the next week and adjusts medication doses accordingly. About 225 adults with opioid-use disorder who are starting methadone or buprenorphine treatment will participate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Opioid-use disorder are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • Rutgers University

    NOT_YET_RECRUITING

    Piscataway, New Jersey, 08854, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.