Study Summary
This trial is testing a new approach to treating opioid use disorder - a vaccine targeted against oxycodone. The goal is to develop a vaccine against oxycodone and heroin. The study will test safety, antibody production, and efficacy.
Eligible Conditions
- Opioid Use Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Throughout the testing session [i.e., pre-dose baseline (Time 0)- Thru- 4.5 hours post-dose].
Week 43
Incidence of Treatment-Emergent Adverse Events
Hour 5
Effects of Vaccine on Intranasal Drug Positive Subjective Effects
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Low Dose Vaccine (100 μg)
1 of 3
High Dose Vaccine (400 μg)
1 of 3
Placebo Vaccine
1 of 3
Experimental Treatment
Non-Treatment Group
45 Total Participants · 3 Treatment Groups
Primary Treatment: OXY 100 mg · Has Placebo Group · Phase 1 & 2
Low Dose Vaccine (100 μg)Experimental Group · 5 Interventions: Oxy 25 mg, OXY 100 mg, OXY 50 mg, Heroin, Placebo · Intervention Types: Drug, Drug, Drug, Drug, Drug
High Dose Vaccine (400 μg)Experimental Group · 5 Interventions: Oxy 25 mg, OXY 100 mg, OXY 50 mg, Heroin, Placebo · Intervention Types: Drug, Drug, Drug, Drug, Drug
Placebo VaccinePlaceboComparator Group · 5 Interventions: Oxy 25 mg, OXY 100 mg, OXY 50 mg, Heroin, Placebo · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diamorphine
FDA approved
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the testing session [i.e., pre-dose baseline (time 0)- thru- 4.5 hours post-dose].
Who is running the clinical trial?
Clinilabs, Inc.OTHER
7 Previous Clinical Trials
450 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
457 Previous Clinical Trials
148,545 Total Patients Enrolled
Sandra D Comer, PhDPrincipal InvestigatorNew York State Psychiatric Institute
7 Previous Clinical Trials
515 Total Patients Enrolled
Eligibility Criteria
Age 18 - 59 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:We are enrolling participants who self-identify their opioid of choice as being other than oxycodone, oxymorphone, hydrocodone, and hydromorphone
The individual is not seeking treatment for drug use at the time of admission, as evidenced by positive results for illicit opioids from urine samples, and negative results for buprenorphine and methadone from at least two separate urine samples, taken with a minimum of three days separating each test.
Capable of following the study schedule and meeting all requirements.
A female must be non-pregnant, non-lactating and either be of non-childbearing potential (sterilized) or of childbearing potential but practicing a birth control method.
The individual meets the current DSM 5 criteria for moderate-severe OUD, physical dependence on opioids and is currently using opioids in amounts and/or frequencies that meet or exceed those used in the study
The subject has been informed of all of the key aspects of the study, and has signed and dated an informed consent form indicating their agreement.
People aged 18 to 59 years old.
People who weigh less than 300 pounds and have a waist size of less than 52 inches are eligible for the study.
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Conditions
Cancer Related
Treatments