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NCT03345173 · ClinicalTrials.gov registry record · Phase 3
Facilitating Rapid Naltrexone Initiation
A Phase 3 study of Opioid Dependence, sponsored by New York State Psychiatric Institute.
- Active
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03345173: Active Phase 3 study of Opioid Dependence, sponsored by New York State Psychiatric Institute.
NCT03345173 is a Phase 3 study of Opioid Dependence that is active but no longer recruiting, run by New York State Psychiatric Institute. The registered enrollment target is 100 participants, below the 155-participant average among 29 other Opioid Dependence trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345173, a Phase 3 study of Opioid Dependence, is active but no longer recruiting, sponsored by New York State Psychiatric Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexone (XR-NTX), an antagonist medication that blocks the effects of opioids for at least 4 weeks, is now indicated for relapse prevention following detoxification. This randomized, controlled trial aims to test the efficacy of a glutamate modulator at facilitating a rapid non-opioid based naltrexone induction.
Primary Outcome
Initiation of XR-NTX during the inpatient induction, without dropout or buprenorphine initiation.
Conditions Studied
Interventions
- DRUG CI-581-a
- DRUG CI-581-b
Study Locations (1)
New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-11-25 |
| Est. Completion | 2024-10 |
| Phase | Phase 3 |
What the registry record for NCT03345173 still lists
NCT03345173 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 155-participant average among 29 other Opioid Dependence trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Opioid Dependence appearing as the primary indexed condition, and to 2 interventions - of which CI-581-a is the first listed.
NCT03345173 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03345173 about?
NCT03345173 is a clinical study titled "Facilitating Rapid Naltrexone Initiation". The incidence of opioid use disorders (OUDs) has increased to near-epidemic proportions. While maintenance with long-acting opioids such as methadone or buprenorphine represents an effective treatment strategy, it may be unacceptable to many individuals. As a result, long-acting injectable naltrexon...
What is the current status of trial NCT03345173?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2017-11-25. Estimated completion is 2024-10.
What conditions does trial NCT03345173 study?
This clinical trial studies the following conditions: Opioid Dependence.
What interventions are being tested in trial NCT03345173?
The interventions under investigation include: CI-581-a (DRUG), CI-581-b (DRUG).
Who is sponsoring clinical trial NCT03345173?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345173 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03345173's enrollment target sits among peer trials
100 15th of 29 higher than 14 of 29 other Opioid Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Dependence 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
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