Smartphones for Opiate Addiction Recovery (SOAR)
Opioid-use Disorder
About this trial
This is an interventional treatment trial for Opioid-use Disorder
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
Sites / Locations
- Rutgers University
- NYU LangoneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
No Intervention
Experimental
Experimental
Experimental
Experimental
Treatment-as-Usual
Smartphone with dose changes after using
Smartphone with dose changes before using
Focus group with Study Physicans
Focus group with Clinicians
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.