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NCT04762537 · ClinicalTrials.gov registry record · NA
Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone
A NA study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- NA
- Development phase
- 415
- Enrollment target
NCT04762537 is a NA study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 415 participants.
The verdict
NCT04762537, a NA study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 415 participants
- Enrollment target
Study Summary
This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs. The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid Method (5-7 day long) is non-inferior to a Standard Method (13-day long) on the primary effectiveness outcome of successful initiation of XR-NTX (receiving the first injection). Secondary objectives include comparing Rapid versus Standard method on: time from admission to first dose of XR-NTX and time to dropout, craving, withdrawal severity, retention, abstinence, and safety measures, as measured during the inpatient induction process and the first two months of post-induction XR-NTX maintenance. Other exploratory outcomes include predictors of initiation success, and economic analyses. The implementation goal is to operationalize an implementation facilitation strategy that will be used to train clinical sites on the XR-NTX initiation method, to capture fidelity to the rapid induction process, and to study barriers and facilitators to implementation and refine the implementation facilitation strategy accordingly.
Interventions
- OTHER Standard Induction Procedure (SP)
- OTHER Rapid Induction Procedure (RP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2022-12-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04762537
The ClinicalTrials.gov registry entry for NCT04762537 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 415 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Induction Procedure (SP) is the first listed.
NCT04762537 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04762537 about?
NCT04762537 is a clinical study titled "Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone". This study compares two methods of initiating treatment with extended-release naltrexone (XR-NTX) when implemented at community-based inpatient or residential programs. The primary goal of this hybrid effectiveness-implementation study is to determine whether the Rapid Method (5-7 day long) is non-i...
What is the current status of trial NCT04762537?
This trial is currently completed. It is a NA study. The enrollment target is 415 participants. The study started on 2021-03-16. Estimated completion is 2022-12-21.
What interventions are being tested in trial NCT04762537?
The interventions under investigation include: Standard Induction Procedure (SP) (OTHER), Rapid Induction Procedure (RP) (OTHER).
Who is sponsoring clinical trial NCT04762537?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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