Clinical Trial

Facilitating Rapid Naltrexone Initiation

Active, Not Recruiting Phase 3
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Record status
This record was last updated February 2, 2024 (before its estimated October 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2017-11-15; most recent amendment 2026-05-19.
Status change: Active, Not Recruiting → Terminated 2025-10-08
Status change: Recruiting → Active, Not Recruiting 2024-02-01
Trial Details
NCT Number NCT03345173
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Dependence
Enrollment 100 participants
Start Date 2017-11-25
Primary Completion 2024-10 (estimated)
Study Completion 2024-10 (estimated)
Updated on ClinicalTrials.gov 2024-02-02