Clinical Trials of Multivalent Opioid Vaccine Components

Part of paid clinical trials in Eatontown, New Jersey.

Sponsor
New York State Psychiatric Institute
Study ID
NCT04458545
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 8, 2020
Status verified
Apr 2026
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Vaccine (high dose or low dose)
    Active Oxy(Gly)4-sKLH vaccine dose (low dose or high dose)
  • Placebo Comparator: Placebo Oxy(Gly)4-sKLH vaccine dose
    Placebo Oxy(Gly)4-sKLH vaccine

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: Beginning from first vaccination through study completion (43 Weeks). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Clinilabs Drug Development CorporationEatontownNew Jersey07724
Ronni Spanola, MS
212-994-4560
New York State Psychiatric Institute: Division on Substance Use DisordersNew YorkNew York10032-

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By research site
Clinilabs Drug Development Corporation· Eatontown, NJNew York State Psychiatric Institute: Division on Substance Use Disorders· New York, NY

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