Phone app predicts relapse to stop opioid abuse during treatment
NCT ID NCT05033028
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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NYU Langone
RECRUITINGNew York, New York, 10016, United States
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Rutgers University
NOT_YET_RECRUITINGPiscataway, New Jersey, 08854, United States
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Other studies related to the condition(s) this trial covers.
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