Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Opioid Use Disorder and Opioid Use, sponsored by Friends Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome of the proposed study is retention in methadone treatment, which will be determined via clinic attendance records, and will be defined as 7 days of continuous absence from scheduled clinic medication visits at any point during the 48-week intervention period.
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 |
What NCT05766631 shows while recruiting
NCT05766631 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower).
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 lists 5 locations in 1 state (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.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05766631's enrollment target sits among peer trials
240 75th of 257 higher than 180 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Buprenorphine for Individuals in Jail
RECRUITING · Phase 3
-
Standard Versus High Dose ED-Initiated Buprenorphine Induction
RECRUITING · Phase 3
-
High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
RECRUITING · Phase 3
-
Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3
RECRUITING · Phase 3
-
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
RECRUITING · Phase 3
-
Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI