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NCT05766631 · ClinicalTrials.gov registry record · Phase 3
Treating Polysubstance Use Using a Novel Digital Technology
A Phase 3 study of Opioid Use Disorder and Opioid Use, sponsored by Friends Research Institute.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 5
- Study locations
NCT05766631 is a Phase 3 study of Opioid Use Disorder and Opioid Use that is actively recruiting participants, run by Friends Research Institute. The registered enrollment target is 240 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT05766631, a Phase 3 study of Opioid Use Disorder and Opioid Use, is actively recruiting participants, sponsored by Friends Research Institute.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL DynamiCare Health
- DRUG Methadone Treatment-As-Usual
Study Locations (5)
Maryland
- Friends Research Institute, Inc. Central Office - Baltimore
- Glenwood Life Counseling Center - Baltimore
- Institutes for Behavior Resources - Baltimore
- Man Alive - Baltimore
- BD Health Services, Inc. -- Dundalk - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-07-26 |
| Est. Completion | 2027-09-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05766631
The ClinicalTrials.gov registry entry for NCT05766631 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The listed sponsor is Friends Research Institute, which has 41 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which DynamiCare Health is the first listed.
NCT05766631 reports 5 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05766631 about?
NCT05766631 is a clinical study titled "Treating Polysubstance Use Using a Novel Digital Technology". 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 long...
What is the current status of trial NCT05766631?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2023-07-26. Estimated completion is 2027-09-29.
What conditions does trial NCT05766631 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Use, Cocaine Use Disorder, Cocaine Use.
What interventions are being tested in trial NCT05766631?
The interventions under investigation include: DynamiCare Health (BEHAVIORAL), Methadone Treatment-As-Usual (DRUG).
Who is sponsoring clinical trial NCT05766631?
This trial is sponsored by Friends Research Institute, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05766631 being conducted?
This trial has 5 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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