EICHORCondition: Opioid-use Disorder · Sponsor: New York State Psychiatric Institute
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. T…
This description comes directly from the study's public registry record.
Jermaine Jones, PhD · 16467746113 · jermaine.jones@nyspi.columbia.edu
Sandra Comer, PhD · Sandra.Comer@nyspi.columbia.edu
Always discuss trial participation with your own doctor first.
| Clinilabs Drug Development Corporation | Eatontown, New Jersey, United States | Recruiting |
| New York State Psychiatric Institute: Division on Substance Use Disorders | New York, New York, United States | Active Not Recruiting |
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Source record: clinicaltrials.gov/study/NCT04458545