Clinical trial NCT05033028: Smartphones for Opiate Addiction Recovery
Official title: Smartphones for Opiate Addiction Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid-use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary goal in this mid-scale clinical trial is to test the hypothesis that clinicians who use the output of the mobile system to adjust buprenorphine and methadone dosing achieve lower opiate reuse rates than physicians who provide care-as-usual. The secondary goal is to examine the usability and desirability of this solution for clinicians with an eye to usability and large-scale deployment. The third and final goal is to measure the cost-effectiveness of this solution from multiple perspectives. If successful it will be possible to employ an algorithmic and measurement-based approach to OUD treatment with methadone and buprenorphine which reduces reuse rates and relapse rates amongst OUD patients.

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU
timeFrame: 1 month visit, 3 months visit, 6 months visit
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stephen Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: