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Oxycodone Vaccine for Opioid Use Disorder

This study is testing a new approach to help people with opioid use disorder (OUD) by using a vaccine. The vaccine, called Oxy(Gly)4-sKLH, aims to create antibodies in your blood that would bind to oxycodone, preventing it from reaching your brain. Researchers are looking for 45 adults, aged 18 to 59, who have OUD but are not currently seeking treatment. The study will compare two different doses of the Oxy(Gly)4-sKLH vaccine against a placebo (an inactive substance). Success will be measured by tracking any side effects, how well your body creates antibodies to the vaccine, and how the vaccine affects the subjective feelings you get from using intranasal oxycodone. The current recruitment status is unclear.

Study design
This study is designed as a placebo-controlled trial with two active vaccine doses. It plans to enroll 45 participants.
What's involved
You would receive vaccinations at Weeks 0, 3, 6, and 18, and participate in various study visits and lab sessions over 42 weeks.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 42 weeks after the first vaccination, with extended follow-up visits until Week 42.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04458545

Clinical Trials of Multivalent Opioid Vaccine Components

Recruiting
PHASE1Ages 18–59InterventionalTreatment
New York State Psychiatric Institute
~45 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Oxy(Gly)4-sKLH vaccine - Low DoseOxy(Gly)4-sKLH vaccine - High DosePlacebo Oxy(Gly)4-sKLH vaccine

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over Beginning from first vaccination through study completion (43 Weeks).
+2 more outcomes measured

Conditions

Opioid-use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

2 sites across 2 states
New Jersey1
New York1

Study leadership

  • Sandra D Comer, PhD · PRINCIPAL_INVESTIGATOR · New York State Psychiatric Institute

Who to contact

Jermaine Jones, PhD
[email protected]
16467746113
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

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).
Elevated liver function tests (i.e., AST and ALT \> 2 times the upper limit of normal).
Impaired renal function (creatinine \> 1.2).
Hypertension (\>140/90).
Asthmatic symptoms within the past 3 years.
Active hepatitis \[e.g. symptomatic with a positive test for hepatitis B (HBsAg), hepatitis C antibody (HCV), HIV1/HIV2 antibody/antigen\].
Significant hepatocellular injury as evidenced by elevated bilirubin levels (\>1.3), or elevated levels (over 3x the upper limit of normal) of aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT).
Creatinine clearance estimated to be less than 60 ml/min.
Current gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition.
Sleep apnea as assessed by the STOP-Bang questionnaire; those with high risk will be excluded from the study
Hemoglobin: Women \<11.5; men \<13. 8. Newly diagnosed HIV infection or known HIV infection with CD4 counts below normal levels, active tuberculosis, or other immunocompromising diseases.

What this trial measures

  • Incidence of Treatment-Emergent Adverse EventsBeginning from first vaccination through study completion (43 Weeks).

    Safety and tolerability of the opioid vaccine.

  • Immune response to Oxy(Gly)4-sklhBaseline, Weeks 0-8, Weeks 10, 12, 14, 18, 19, 20, 23, 34, 42

    Antibody titers, concentrations, affinity for oxycodone, cross-reactivity to off-target opioid agonists and antagonists (including endogenous opioid neuropeptides), and subclasses of the serum IgG antibodies will be measured at baseline and repeatedly over the course of the study period to characterize the magnitude and duration of the antibody response to vaccination.

  • Effects of Vaccine on Intranasal Drug Positive Subjective EffectsThroughout the testing session [i.e., pre-dose baseline (Time 0)- Thru- 4.5 hours post-dose].

    Peak self-reported drug "Liking." Measured using a visual analog scale (0-100).