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Opioid Receptor Agonist
Opioid Receptor Binding Analysis for Healthy Subjects
Phase 1
Recruiting
Led By Jacob Dubroff, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial will use brain imaging to study the effects of opioids and an antidote to opioids in 20 healthy people.
Who is the study for?
This trial is for healthy adults aged 18-50, fluent in English, who can consent to participate. It includes those with opioid use disorder (OUD) on stable medication-assisted treatment (MAT), those with OUD not on MAT, and healthy controls without OUD. Pregnant or breastfeeding women, individuals with certain medical conditions or metal implants incompatible with MRI scans are excluded.Check my eligibility
What is being tested?
The study tests how the body's opioid receptors bind to substances by using PET imaging with [11C]carfentanil. Participants will undergo two scan sessions; one baseline and another after receiving naloxone which blocks opioid binding. The aim is to compare receptor activity between different groups of participants.See study design
What are the potential side effects?
Potential side effects may include typical reactions from PET imaging agents like discomfort at the injection site or allergic reactions. Naloxone can cause withdrawal symptoms in people dependent on opioids and other minor side effects such as nausea or headache.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow up - 1 day to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow up - 1 day to 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MOR BPND measurement - [11C]carfentanil
MOR BPND measurement - naloxone and [11C]carfentanil
Trial Design
3Treatment groups
Experimental Treatment
Group I: Opioid Use Disorder and Medication Assisted Treatment (OUD+/MAT-)Experimental Treatment2 Interventions
Study imaging will be performed using a whole-body PET/CT scanner.
Each participant will receive ≤ 10 mCi of [11C]carfentanil intravenously (approximate range for most studies is anticipated to be 2-10 mCi ).
Participants will undergo dynamic PET/CT imaging of the brain and body. The scan will take approximately 90 minutes for each scan session. Study imaging will be performed using a whole-body PET/CT scanner.
For the first study scan, participants will receive [11C]carfentanil radiotracer alone. For the second study scan approximately 13 mcg/kg of naloxone will be administered by IV prior to the [11C]carfentanil injection. If both scans are done the same day, then the naloxone injection will be given before the second scan session and there will be a break between the two scan sessions of approximately 3 hours.
Group II: Opioid Use Disorder Only (OUD+/MAT-)Experimental Treatment2 Interventions
Study imaging will be performed using a whole-body PET/CT scanner.
Each participant will receive ≤ 10 mCi of [11C]carfentanil intravenously (approximate range for most studies is anticipated to be 2-10 mCi ).
Participants will undergo dynamic PET/CT imaging of the brain and body. The scan will take approximately 90 minutes for each scan session. Study imaging will be performed using a whole-body PET/CT scanner.
For the first study scan, participants will receive [11C]carfentanil radiotracer alone. For the second study scan approximately 13 mcg/kg of naloxone will be administered by IV prior to the [11C]carfentanil injection. If both scans are done the same day, then the naloxone injection will be given before the second scan session and there will be a break between the two scan sessions of approximately 3 hours.
Group III: Healthy Volunteers (OUD-)Experimental Treatment2 Interventions
Study imaging will be performed using a whole-body PET/CT scanner.
Each participant will receive ≤ 10 mCi of [11C]carfentanil intravenously (approximate range for most studies is anticipated to be 2-10 mCi ).
Participants will undergo dynamic PET/CT imaging of the brain and body. The scan will take approximately 90 minutes for each scan session. Study imaging will be performed using a whole-body PET/CT scanner.
For the first study scan, participants will receive [11C]carfentanil radiotracer alone. For the second study scan approximately 13 mcg/kg of naloxone will be administered by IV prior to the [11C]carfentanil injection. If both scans are done the same day, then the naloxone injection will be given before the second scan session and there will be a break between the two scan sessions of approximately 3 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
2014
Completed Phase 3
~1240
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,149 Total Patients Enrolled
Jacob Dubroff, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania, Perelman School of Medicine, Department of Radiology
4 Previous Clinical Trials
279 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medication for alcohol use disorder or heavy drinking.I have a history of epilepsy, seizures, head injury, or brain tumor.I haven't taken any antipsychotic, anticonvulsant, or stimulant medication in the last month that could interfere with my treatment.I am between 18 and 50 years old.I speak English fluently and can sign consent forms in English.I haven't taken any mental health or strong pain medications in the last year.I am allergic to opioids or naloxone.I haven't taken naltrexone or similar medications in the last year.I cannot have an MRI due to incompatible metal in my body.I have never had epilepsy, seizures, head trauma, or a brain tumor.I have a major psychiatric condition that affects certain medication interactions.I have used medications like naltrexone or methadone in the past year.I have never been diagnosed with opioid use disorder and haven't used opioids in the last 30 days.I speak English fluently and can sign consent forms in English.I am using medication to help me stop smoking.I am a healthy adult between 18 and 50 years old.I have a severe addiction other than opioid use that could affect the study.I have a history of opioid use disorder but have been opioid-free and without medication-assisted treatment for it in the past year.I have a history of epilepsy, seizures, head injury, or brain tumor.I am between 18 and 50 years old.I have a major psychiatric condition that needs medication affecting opioid receptors.I have opioid use disorder and have been on a stable dose of buprenorphine or methadone for at least 4 weeks.I cannot have an MRI due to incompatible metal in my body.I haven't taken any medication in the past year that affects radiotracer binding.I have a history of opioid use disorder but haven't used opioids or received treatment for it in the last 12 months.I recently stopped taking drugs that could affect the study's tests.I have been diagnosed with opioid use disorder and have been on a stable dose of buprenorphine or methadone for at least 4 weeks.I am between 18 and 50 years old.I am between 18 and 50 years old and in good health.You are able to understand and communicate in English.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid Use Disorder Only (OUD+/MAT-)
- Group 2: Opioid Use Disorder and Medication Assisted Treatment (OUD+/MAT-)
- Group 3: Healthy Volunteers (OUD-)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can new participants still join this experiment?
"As per clinicaltrials.gov, this trial is actively seeking participants; the initial post date was September 20th 2022 and it has been updated most recently on October 13th of that same year."
Answered by AI
How many participants are participating in this trial?
"Confirmed. According to the information on clinicaltrials.gov, this medical study is still recruiting participants since its inception date of September 20th 2022 and most recent update from October 13th 2022. The study currently requires 20 patients at a single location for completion."
Answered by AI
Has Carfentanil, C-11 been given the sanction of governmental regulatory bodies?
"Carfentanil, C-11 was rated 1 on our safety scale due to this being a Phase 1 trial and little evidence of its efficacy or lack thereof."
Answered by AI
How might I enroll in this clinical experiment?
"Within the parameters of 18 to 50 years old, this clinical trial is recruiting 20 healthy individuals (HS) that are proficient in English and able to provide informed consent. The recruitment process also necessitates compliance with institutional and federal guidelines before any study-specific procedures take place."
Answered by AI
Are senior citizens excluded from this trial's participation criteria?
"Admittance into this clinical trial is restricted to individuals between the ages of 18 and 50. Meanwhile, those below the age of legal majority have access to 50 trials while elderly participants can join 372 studies."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania, Perelman School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Actually I am on methadone. It didn't have that as an option. I need the money, I want to help the research study, and I'm curious to see if somt.
PatientReceived no prior treatments
I am a healthy person looking to get involved with research studies with compensation.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long does it take become enrolled? How long do visits take and is there any compensation?
PatientReceived 1 prior treatment
What time/effort commitment is required for this study? What compensation is provided to compensate said time and effort?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
- University of Pennsylvania, Perelman School of Medicine: < 24 hours
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