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NCT04365920 · ClinicalTrials.gov registry record · Phase 3
Recovery Management Checkups for Opioid Use Disorder Experiment
A Phase 3 study of Opioid Use Disorder, sponsored by Chestnut Health Systems.
- Active
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
- 1
- Study location
NCT04365920: Active Phase 3 study of Opioid Use Disorder, sponsored by Chestnut Health Systems.
NCT04365920 is a Phase 3 study of Opioid Use Disorder that is active but no longer recruiting, run by Chestnut Health Systems. The registered enrollment target is 455 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365920, a Phase 3 study of Opioid Use Disorder, is active but no longer recruiting, sponsored by Chestnut Health Systems.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
- 1
- Study location
Study Summary
The experiment will be conducted in collaboration with 6 jails representing discrete geographic counties in Illinois and the opioid treatment providers (OTP) that serve them. It will compare a re-entry as usual control group with two experimental groups in terms of their impact on the OUD service cascade, as well as public health and public safety outcomes. Study recruitment sites are six jails that provide treatment with medication for opioid use disorder (MOUD) to inmates with OUD prior to their release. At the time of their release to the community, 750 men and women will be randomly assigned to 1 of 3 groups: a) a re-entry as usual control, b) RMC with monthly checkups for 3 months post-release followed by quarterly checkups up to 2 years, or c) an adaptive version of RMC (RMC-A) that includes a modified checkup schedule based on each individual's pattern of treatment need. All participants will complete research interviews at release and quarterly thereafter up to 2 years post-enrollment.
Primary Outcome
A continuous measure of months of treatment with MOUD received from opioid treatment provider records (Interclass Correlation Coefficient \[ICC\]=.37 when measured quarterly). The count will be based on days of medication received (including any take-home dosages); injectable naltrexone will be counted as treatment for 30 days. Missing records data will be estimated from self-report.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Recovery Management Checkups (RMC)
- COMBINATION_PRODUCT RMC-Adaptive
Study Locations (1)
Illinois
- Chestnut Health Systems-Lighthouse Institute - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2021-08-29 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04365920 still lists
NCT04365920 is an interventional study that assigns participants to a tested intervention. The registered 455 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 (90% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Recovery Management Checkups (RMC) is the first listed.
NCT04365920 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04365920 about?
NCT04365920 is a clinical study titled "Recovery Management Checkups for Opioid Use Disorder Experiment". The experiment will be conducted in collaboration with 6 jails representing discrete geographic counties in Illinois and the opioid treatment providers (OTP) that serve them. It will compare a re-entry as usual control group with two experimental groups in terms of their impact on the OUD service ca...
What is the current status of trial NCT04365920?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2021-08-29. Estimated completion is 2025-06-30.
What conditions does trial NCT04365920 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT04365920?
The interventions under investigation include: Recovery Management Checkups (RMC) (COMBINATION_PRODUCT), RMC-Adaptive (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04365920?
This trial is sponsored by Chestnut Health Systems, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04365920 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04365920's enrollment target sits among peer trials
455 40th of 257 higher than 218 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.
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