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Facilitating Rapid Naltrexone Initiation

StatusActive, Not Recruiting
PhasePhase 3
Started
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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.

Record History

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  1. Primary and study completion dates: Oct 2023 to Oct 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  2. Primary and study completion dates: Oct 2022 to Oct 2023v8
  3. Re-verified, no change to tracked fieldsv7
  4. Primary and study completion dates: Oct 2021 to Oct 2022
    • Eligibility criteria expanded, about 30 words
    v6
  5. Re-verified, no change to tracked fieldsv5
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  1. Eligibility criteria shortened, about 45 wordsv4
  2. Re-verified, no change to tracked fieldsv3
  3. Study title shortened, about 6 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03345173
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Opioid Dependence
Related terms Opioid-Related Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov