Using smartphones to help recover from opioid addiction

Smartphones for Opiate Addiction Recovery

This study tests if a smartphone app can help people recovering from opioid addiction by giving doctors better information to adjust their treatment and see if it leads to less use of illegal opioids.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 2 sites (Piscataway, New Jersey and 1 other locations)
• Trial ID: NCT05033028 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who meet DSM-5 criteria for opioid-use disorder and are entering a treatment program that prescribes methadone or buprenorphine.

Not a fit: Patients who do not meet the criteria for opioid-use disorder or those who are not entering a treatment program for methadone or buprenorphine may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce relapse rates in patients recovering from opioid addiction.

How similar studies have performed: Other studies have shown promise in using technology to support addiction recovery, indicating that this approach may be viable.

Eligibility criteria

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 this trial is running

Piscataway, New Jersey and 1 other locations

• Rutgers University — Piscataway, New Jersey, United States (Not_yet_recruiting)
• NYU Langone — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Stephen Ross, MD — NYU Langone Health
• Study coordinator: Paul Glimcher

Conditions Opioid-use Disorder