Using smartphones to help recover from opioid addiction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a smartphone app designed to assist in the treatment of opioid-use disorder (OUD) by providing clinicians with data to adjust medication dosages. The primary focus is to determine if using this app can lead to lower rates of illicit opiate reuse compared to standard care. Additionally, the study will assess the app's usability for clinicians and its cost-effectiveness from various perspectives. By employing a measurement-based approach, the trial seeks to enhance treatment outcomes for patients undergoing OUD therapy with methadone or buprenorphine.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone
  New York, New York, United States Recruiting
• Rutgers University
  Piscataway, New Jersey, United States Not yet recruiting

Study contacts

• Principal investigator: Stephen Ross, MD — NYU Langone Health
• Study coordinator: Paul Glimcher
• Email: Paul.glimcher@nyulangone.org
• Phone: 212-263-8167

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

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  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

  Recruiting Friends Research Institute, Inc. · Philadelphia, Pennsylvania · NCT07787039

• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.