NCT04458545 · New York State Psychiatric Institute
Clinical Trials of Multivalent Opioid Vaccine Components
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
Oxy(Gly)4-sKLH vaccine - Low Dose
Oxy(Gly)4-sKLH vaccine - Low Dose
BIOLOGICAL
Oxy(Gly)4-sKLH vaccine - High Dose
Oxy(Gly)4-sKLH vaccine - high dose
BIOLOGICAL
Placebo Oxy(Gly)4-sKLH vaccine
Oxy(Gly)4-sKLH vaccine - Placebo
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Time frame: Beginning from first vaccination through study completion (43 Weeks).
Safety and tolerability of the opioid vaccine.
Immune response to Oxy(Gly)4-sklh
Time frame: Baseline, 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 Effects
Time frame: Throughout 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Males and females aged 18 to 59 years. 3. Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of childbearing potential but practicing a medically acceptable method of birth control 4. Meets current DSM 5 criteria for moderate-severe Psychiatric OUD, physical dependence on opioids, and current use of Examination opioids will be in amounts and/or frequencies that meet or exceed those used in the study (3-4 tablets of a prescription opioid medication per day or 1-2 bags of heroin and/or fentanyl per day). Participants may meet criteria for other behavioral disorders (e.g. gambling) or substance use disorders (cocaine or marijuana), but cannot be physically dependent on drugs that pose risk of with
Where
- Eatontown, New Jersey
- New York, New York
Collaborators
Clinilabs, Inc., National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations