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NCT04458545 · ClinicalTrials.gov registry record · Phase 1

Clinical Trials of Multivalent Opioid Vaccine Components

A Phase 1 study of Opioid Use Disorder, sponsored by New York State Psychiatric Institute.

Recruiting
Registry status
Phase 1
Development phase
45
Enrollment target
2
Study locations

NCT04458545: Recruiting Phase 1 study of Opioid Use Disorder, sponsored by New York State Psychiatric Institute.

NCT04458545 is a Phase 1 study of Opioid Use Disorder that is actively recruiting participants, run by New York State Psychiatric Institute. The registered enrollment target is 45 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04458545, a Phase 1 study of Opioid Use Disorder, is actively recruiting participants, sponsored by New York State Psychiatric Institute.

RECRUITING
Registry status
Phase 1
Development phase
45 participants
Enrollment target
2
Study locations

Study Summary

Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study is designed to examine a new approach to treating OUD, namely use of a vaccine targeted against oxycodone \[Oxy(Gly)4-sKLH\], one of the most commonly abused prescription opioids. The vaccination approach to treating substance use disorders relies on the ability of the vaccine to produce antibodies that bind the target drug in blood and reduce its ability to enter the brain. The long-term goal of this research will be to develop a combined vaccine against oxycodone and heroin. However, in this trial the Oxy(Gly)4-sKLH vaccine will be studied separately. This is a multi-site study, being conducted at the New York State Psychiatric Institute and the Clinilabs clinical research unit (CRU) in Eatontown, New Jersey. The current study proposes to evaluate safety (Aim 1), degree of antibody production (Aim 2), and efficacy (i.e., ability to reduced drug liking following opioid administration) (Aim 3). The oxycodone vaccine (Oxy(Gly)4-sKLH) will be tested in participants with OUD (target # completers = 45 across two study sites). This study will provide a great deal of information about the safety and potential effectiveness of the Oxy(Gly)4-sKLH vaccine in reducing the abuse of opioids. The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Primary Outcome

Safety and tolerability of the opioid vaccine.

Conditions Studied

Opioid Use Disorder

Interventions

  • BIOLOGICAL Oxy(Gly)4-sKLH vaccine - Low Dose
  • BIOLOGICAL Oxy(Gly)4-sKLH vaccine - High Dose
  • BIOLOGICAL Placebo Oxy(Gly)4-sKLH vaccine

Study Locations (2)

New Jersey

  • Clinilabs Drug Development Corporation - Eatontown

New York

  • New York State Psychiatric Institute: Division on Substance Use Disorders - New York

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2020-10-08
Est. Completion 2026-03-30
Phase Phase 1
New York State Psychiatric Institute

364 total trials

What NCT04458545 shows while recruiting

NCT04458545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Oxy(Gly)4-sKLH vaccine - Low Dose is the first listed.

NCT04458545 reports a single indexed study location in New Jersey, New York.

Frequently Asked Questions

What is clinical trial NCT04458545 about?

NCT04458545 is a clinical study titled "Clinical Trials of Multivalent Opioid Vaccine Components". Currently, abuse of prescription opioid analgesics and heroin is a serious problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current study i...

What is the current status of trial NCT04458545?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2020-10-08. Estimated completion is 2026-03-30.

What conditions does trial NCT04458545 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT04458545?

The interventions under investigation include: Oxy(Gly)4-sKLH vaccine - Low Dose (BIOLOGICAL), Oxy(Gly)4-sKLH vaccine - High Dose (BIOLOGICAL), Placebo Oxy(Gly)4-sKLH vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT04458545?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04458545 being conducted?

This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Opioid Use Disorder

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 NCT04458545's enrollment target sits among peer trials

45 182nd of 257 higher than 76 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04458545

Source: ClinicalTrials.gov NCT04458545, the US trial registry maintained by the National Library of Medicine. NCT04458545 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.