Phase 1a1b Study of Oxycodone Vaccine for Opioid Use Disorder in Adults Aged 18 to 59

What this Trial Is About

Researchers are evaluating a new approach to treating opioid use disorder OUD by studying a vaccine targeted against oxycodone, one of the commonly abused prescription opioids. This Phase 1a1b clinical trial aims to assess the safety, immune response, and effectiveness of the OxyGly4-sKLH vaccine in adults aged 18 to 59 years who meet criteria for moderate to severe OUD and are physically dependent on opioids. The study is supported by the New York State Psychiatric Institute and includes participants not currently seeking treatment for their opioid use. The study compares two doses of the OxyGly4-sKLH vaccine low and high dose to a placebo, administered by injection into the deltoid muscle at Weeks 0, 3, 6, and 18. Participants will be randomly assigned to one of these groups in a triple-masked design. The trial includes several phases a screening phase lasting from 6 to 2 weeks before vaccination, an outpatient study visit phase from Week 0 to Week 21, three laboratory sessions at Weeks -1, 7, and 19, and an extended follow-up period from Weeks 23 to 42. During the approximately 42-week participation, individuals will undergo safety monitoring for adverse events, assessments of immune response to the vaccine, and evaluations of the vaccines effect on drug liking after opioid administration. Assessments include blood tests for antibodies, urine drug screens, and subjective effect measures during testing sessions lasting up to 4.5 hours post-dose. Participants must comply with scheduled visits, dosing, and lab tests, with continuous monitoring for safety and immune response throughout the study.

Clinical Trials of Multivalent Opioid Vaccine Components