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Clinical Trials of Multivalent Opioid Vaccine Components

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary and study completion dates: Mar 30, 2026 to Mar 30, 2027v14
  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion date: Dec 30, 2026 to Mar 30, 2026
    • Study completion date: Apr 30, 2027 to Mar 30, 2026
    v12
  4. Primary completion date: Dec 30, 2024 to Dec 30, 2026v11 Show 8 more changesShow less
    • Primary endpoints: 2 to 3
    • Study completion date: Apr 30, 2025 to Apr 30, 2027
    • Interventions: Heroin (Drug), OXY 100 mg (Drug), OXY 50 mg (Drug), Oxy 25 mg (Drug), Placebo (Drug) to Oxy(Gly)4-sKLH vaccine - High Dose (Biological), Oxy(Gly)4-sKLH vaccine - Low Dose (Biological), Placebo Oxy(Gly)4-sKLH vaccine (Biological)
    • Eligibility criteria shortened, about 948 words
    • Study description shortened, about 430 words
    • Site contacts updated at 1 of 2 sites
    • Collaborators: 1 to 2
    • Study arms: 3 to 2
  5. Primary completion date: Dec 30, 2023 to Dec 30, 2024
    • Study completion date: Dec 30, 2023 to Apr 30, 2025
    • Eligibility criteria expanded, about 1,081 words
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 1 to 2v9
  2. Start date: May 4, 2021 to Oct 8, 2020v8
  3. Re-verified, no change to tracked fieldsv7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 31, 2021 to May 4, 2021
    • Study site revised
    v6
  5. Start date: Mar 31, 2021 to May 31, 2021v5
  6. Start date: Dec 31, 2020 to Mar 31, 2021v4
  7. Start date: Sep 15, 2020 to Dec 31, 2020
    • Primary completion date: Jul 30, 2023 to Dec 30, 2023
    v3
  8. Start date: Jul 15, 2020 to Sep 15, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT04458545
Lead Sponsor New York State Psychiatric Institute
Collaborators: Clinilabs, Inc., National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Opioid-use Disorder
Related terms Opioid-Related Disorders
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov