RecruitingPhase 3

Smartphones for Opiate Addiction Recovery

United States225 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 month visit, 3 months visit, 6 months visit

Trial details

NCT IDNCT05033028

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Paul Glimcher

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

View on ClinicalTrials.gov More Opioid-use Disorder trials