search
Back to results

Smartphones for Opiate Addiction Recovery (SOAR)

Primary Purpose

Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone app
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers University
  • NYU LangoneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment-as-Usual

Smartphone with dose changes after using

Smartphone with dose changes before using

Focus group with Study Physicans

Focus group with Clinicians

Arm Description

Participants will receive the same treatment as if they had not joined the study

Participants will have an app installed on their phone and have to complete a brief questionnaire and some days play a 2-4 minute game.

Participants will have an app installed on their phone and have to complete a brief questionnaire and some days to play a 2-4 minute game.

Study physicians asked to participate in a focus group session or 1:1 interviews if unable to attend the focus group during year one of the study and once annually towards the end of years 2, 3, 4, and 5 of the study

Clinicians asked to participate in a 1:1 interview and a separate focus group at roughly the same time. Prior to the first structured interview with our study team, you will participate in a 1-hour training and familiarization session with the SOAR system using synthetic or training data.

Outcomes

Primary Outcome Measures

Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).
This is measured by collecting one salivary drug test every two weeks in addition to any drug testing they may complete as part of their clinical treatment. Once saliva samples are obtained they will be aggregated and sent weekly for analysis by mass spectrometry. The primary outcome from these data will be the number of toxicology tests positive for illicit opioids. These data are count in nature and truncated at both 0 and 12.

Secondary Outcome Measures

To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU
This will be measured through self reports through the smartphone and assessed by randomly scheduled, remote drug screens with saliva samples.

Full Information

First Posted
August 27, 2021
Last Updated
May 18, 2023
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05033028
Brief Title
Smartphones for Opiate Addiction Recovery
Acronym
SOAR
Official Title
Smartphones for Opiate Addiction Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment-as-Usual
Arm Type
No Intervention
Arm Description
Participants will receive the same treatment as if they had not joined the study
Arm Title
Smartphone with dose changes after using
Arm Type
Experimental
Arm Description
Participants will have an app installed on their phone and have to complete a brief questionnaire and some days play a 2-4 minute game.
Arm Title
Smartphone with dose changes before using
Arm Type
Experimental
Arm Description
Participants will have an app installed on their phone and have to complete a brief questionnaire and some days to play a 2-4 minute game.
Arm Title
Focus group with Study Physicans
Arm Type
Experimental
Arm Description
Study physicians asked to participate in a focus group session or 1:1 interviews if unable to attend the focus group during year one of the study and once annually towards the end of years 2, 3, 4, and 5 of the study
Arm Title
Focus group with Clinicians
Arm Type
Experimental
Arm Description
Clinicians asked to participate in a 1:1 interview and a separate focus group at roughly the same time. Prior to the first structured interview with our study team, you will participate in a 1-hour training and familiarization session with the SOAR system using synthetic or training data.
Intervention Type
Other
Intervention Name(s)
Smartphone app
Intervention Description
SOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout.
Primary Outcome Measure Information:
Title
Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU).
Description
This is measured by collecting one salivary drug test every two weeks in addition to any drug testing they may complete as part of their clinical treatment. Once saliva samples are obtained they will be aggregated and sent weekly for analysis by mass spectrometry. The primary outcome from these data will be the number of toxicology tests positive for illicit opioids. These data are count in nature and truncated at both 0 and 12.
Time Frame
1 month visit, 3 months visit, 6 months visit
Secondary Outcome Measure Information:
Title
To assess the impact of POSTUSE-DOSING on reuse rates relative to TAU
Description
This will be measured through self reports through the smartphone and assessed by randomly scheduled, remote drug screens with saliva samples.
Time Frame
1 month visit, 3 months visit, 6 months visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Glimcher
Phone
212-263-8167
Email
Paul.glimcher@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rotrosen, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Konova, MD
Phone
929-390-8905
Email
anna.konova@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Anna Konova, MD
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Glimcher
Phone
212-263-8167
Email
paul.glimcher@nyulangone.org
First Name & Middle Initial & Last Name & Degree
John Rotrosen, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Upon reasonable request. Requests should be directed to Paul.glimcher@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Smartphones for Opiate Addiction Recovery

We'll reach out to this number within 24 hrs