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Treating Polysubstance Use Using a Novel Digital Technology

Study acronym: POLY
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Study sites: 6 to 5v5
  4. Minor Study sites: 4 to 6v4
  5. Notable Phase: Not applicable to Phase 3
    • Primary completion date: Nov 2027 to Jun 30, 2027
    • Study completion date: Feb 2028 to Sep 29, 2027
    • Start date: Jul 20, 2023 to Jul 26, 2023
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Jul 20, 2023
    • Site details revised at 4 of 4 sites
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to determine the effects of an app to reduce opioid and cocaine use when layered atop methadone treatment as usual among people using both opioids and cocaine. The main questions it aims to answer are: * Do people who use the app remain in methadone treatment longer than people who receive only treatment as usual? * Do people who use the app report using opioids and/or cocaine less often, and do they report better improvements in their quality of life, than people who receive only treatment as usual? * Does using the app more lead to better methadone treatment outcomes among people using the app? Participants in this study will be randomly assigned to receive either the app or methadone treatment as usual. Participants randomly assigned to the treatment as usual group will receive access to methadone services as normally provided, including scheduled access to medications, information about the consequences of opioid and other drug use, and any onsite services (including group based interventions and/or 12-step programs). Those randomized into the app-using group will receive all the same services as the treatment as usual group, but will also be given a phone with the app already installed, or will have the app installed on their existing phone if they already have one. At random times throughout the week, the app will ask participants to submit drug tests for opioids and cocaine, which participants will be able to do remotely without having to physically "go to" a testing site. For each test that demonstrates the participant hasn't used opioids or cocaine, the participant will be rewarded with money directly into a debit card. Participants will also be able to earn rewards for picking up treatment-related medications, attending onsite appointments, and other treatment-related activities.
Trial Details
NCT Number NCT05766631
Lead Sponsor Friends Research Institute, Inc.
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)
Opioid Use, Opioid Use Disorder, Cocaine Use, Cocaine Use Disorder
Related terms Opioid-Related Disorders
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov