Clinical Trials of Multivalent Opioid Vaccine Components
Eligible age
18–59 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: New York State Psychiatric Institute
You may not qualify if…
- ✕ 1. Participation in a clinical trial and receipt of investigational drug(s) during 30 days (or 5 half-lives, whichever is longer) prior to randomization.
- ✕ 2. Sensitivity, allergy, or contraindication to opioids, alum, or any components of the vaccine
- ✕ 3. Prior exposure to opioid vaccines or vaccines containing Keyhole Limpet Hemocyanin.
- ✕ 4. Use of prescription psychotropic medications that would potentially interfere with study procedures
- ✕ 5. Women of childbearing age who are pregnant, lactating or, not practicing or willing to begin a medically acceptable method of birth control.
- ✕ 6. Cannot read or understand the self-report assessment forms unaided or are so severely disabled that they cannot comply with the requirements of the study.
- ✕ 7. Medical conditions that may make study participation hazardous:
- ✕ History of seizures or cardiac risk conditions (unstable angina, cardiac arrhythmias, chest pain, strong palpitations (subjectively defined as the feeling that the heart is beating too hard, too fast, skipping a beat, or fluttering).
Where it's recruiting
Eatontown
New York
Source: ClinicalTrials.gov · NCT04458545 · last updated 2026-04-23