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Opioid Vaccine for Opioid Use Disorder
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I am allergic to opioids, alum, or vaccine ingredients.I have not had cancer or cancer treatment in the last year.I am not allergic to lactose.I weigh less than 300 pounds and my waist is less than 52 inches.My liver tests show high bilirubin or AST and ALT levels.I have a current stomach condition like an ulcer, gastritis, or any stomach cancer.I am not on any psychiatric drugs that could affect the study.I have not received any blood products in the last 3 months.I have HIV with low CD4 counts, active tuberculosis, or another disease that weakens my immune system.I have been diagnosed with mild to moderate depression and have not had thoughts of suicide in the past month.I am on medication for opioid addiction (like buprenorphine or methadone).You have certain medical conditions that could make it risky for you to participate in the study.You had a severe or unexpected bad reaction to a vaccine before, like Guillain-Barré syndrome.I have been experiencing pain for more than 3 months.I have a history of seizures or heart-related issues.My kidney function is impaired with creatinine levels above 1.2.I haven't taken steroids, antihistamines, or immune-suppressing drugs in the last 30 days.I have not received any vaccines, except for the flu shot, in the last 30 days.I am between 18 and 59 years old.I have not taken part in a clinical trial or received investigational drugs within the last 30 days or 5 half-lives, whichever is longer.I have a severe opioid use disorder but am not dependent on alcohol or benzodiazepines.I have never received opioid vaccines or vaccines with Keyhole Limpet Hemocyanin.I am not pregnant, breastfeeding, and I use or am willing to use birth control.I do not have active hepatitis or HIV.I have had an opiate overdose in the last 2 years.I am not pregnant or breastfeeding, and I cannot become pregnant or am using birth control.I use opioids other than oxycodone or hydrocodone, mainly heroin, and I use it through the nose.I have had asthma symptoms in the last 3 years.
- Group 1: Low Dose Vaccine (100 μg)
- Group 2: High Dose Vaccine (400 μg)
- Group 3: Placebo Vaccine
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are the enrollment criteria of this clinical trial inclusive of those aged 55 and over?
"All eligible participants should be between 18 and 59 years old."
Are there currently opportunities to join this experiment?
"According to the clinicaltrials.gov website, this research project is presently recruiting patients. This trial was initiated on May 4th 2021 and has been revised most recently on July 1st 2022."
Could you explain other experiments conducted with OXY 100 mg?
"Currently, there is 1 active study examining the effects of OXY 100 mg. Unfortunately, none of these studies are in Phase 3 yet. The primary location for this research is based out of New york City; however, there is one additional trial site conducting similar work."
What is the maximum number of participants for this research endeavor?
"Affirmative. Clinicaltrials.gov confirms that this medical study, which was first published on 4th May 2021, is still accepting requests for participation. 45 participants need to be recruited from a single site."
Who has the ability to register for this clinical investigation?
"This trial is admitting 45 individuals suffering from opioid addiction aged between 18 and 59. The most significant criteria are: self-identification of a drug other than oxycodone, oxymorphone, hydrocodone or hydromorphone as the chosen narcotic; experience with intranasal intake of opioids; daily consumption ranging from 1 to 15 bags of heroin (alternatively 3-4 tablets); no current treatment for narcotics abuse proven by two urine samples testing negative for buprenorphine and methadone separated at least three days apart; non pregnant women either not capable or practicing accepted contraception methods if fertile and males/"
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