Smartphones for Opiate Addiction Recovery

Part of paid clinical trials in Piscataway, New Jersey.

Sponsor
NYU Langone Health
Study ID
NCT05033028
Phase
PHASE3
Status
Recruiting
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Conditions

  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Smartphone app — OTHER
    SOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout.

Study Details

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.

Key Dates

Start date
Nov 1, 2021
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Treatment-as-Usual
    Participants will receive the same treatment as if they had not joined the study
  • Experimental: Smartphone with dose changes after using
    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.
  • Experimental: Smartphone with dose changes before using
    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.
  • Experimental: Focus group with Study Physicans
    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
  • Experimental: Focus group with Clinicians
    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.

Primary Outcome Measure

Proportion of patients will reduce illicit substance reuse rates with PREDICTIVE-DOSING relative to treatment as usual (TAU). [ Time Frame: 1 month visit, 3 months visit, 6 months visit ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers UniversityPiscatawayNew Jersey08854
Anna Konova, MD
[email protected]
929-390-8905
Anna Konova, MD (PRINCIPAL_INVESTIGATOR)
NYU LangoneNew YorkNew York10016
Paul Glimcher
[email protected]
212-263-8167
Stephen Ross, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Rutgers University· Piscataway, NJNYU Langone· New York, NY

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