Smartphones for Opiate Addiction Recovery (SOAR)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    510
  • sponsor
    NYU Langone Health
Updated on 20 June 2022

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.

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.

Details
Condition Opioid-use Disorder
Treatment Smartphone APP
Clinical Study IdentifierNCT05033028
SponsorNYU Langone Health
Last Modified on20 June 2022

Eligibility

Yes No Not Sure

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
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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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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