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Diagnostic Test

11UCB-J PET Imaging for Cocaine and Opioid Addiction

N/A
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 criteria for Cocaine Use Disorder or Opiate Use Disorder
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minute scan
Awards & highlights

Study Summary

This trial is looking at how different addictions affect the brain. They will be doing this by looking at the synaptic density in the brains of people with cocaine or opiate addiction, and comparing it to people without addiction.

Who is the study for?
This trial is for adults aged 21-55 with Cocaine or Opiate Use Disorder who've been abstinent (cocaine for 2 weeks, opiates for 4 weeks). They must be physically healthy, not pregnant, have no major psychiatric disorders other than addiction, and not use certain medications. IQ should be above 80.Check my eligibility
What is being tested?
The study tests if synaptic density in the brain of those with Cocaine or Opiate Use Disorder differs from healthy individuals using an imaging technique called 11UCB-J PET scan. It's a first-of-its-kind study to understand addiction-related changes in the brain.See study design
What are the potential side effects?
Since this trial involves only a PET scan, side effects are minimal but may include discomfort at the injection site for tracer administration and potential reactions to the tracer used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You meet the specific criteria for Cocaine Use Disorder or Opiate Use Disorder as defined in the DSM-5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minute scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minute scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
11C-UCB-J PET synaptic density

Trial Design

3Treatment groups
Experimental Treatment
Group I: Opiate Use Disorder (OUD)Experimental Treatment1 Intervention
30 subjects meeting opiate dependence criteria will receive 11UCB-J PET Scan.
Group II: Healthy Controls (HC)Experimental Treatment1 Intervention
30 healthy controls; no substance dependence or mental health issues 11UCB-J PET Scan.
Group III: Cocaine Use Disorder (CUD)Experimental Treatment1 Intervention
30 subjects meeting cocaine dependence criteria 11UCB-J PET Scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11UCB-J PET Scan
2019
N/A
~20

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,838 Previous Clinical Trials
2,729,039 Total Patients Enrolled
3 Trials studying Opioid Addiction
423 Patients Enrolled for Opioid Addiction

Media Library

11UCB-J PET Scan (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03527485 — N/A
Opioid Addiction Research Study Groups: Opiate Use Disorder (OUD), Cocaine Use Disorder (CUD), Healthy Controls (HC)
Opioid Addiction Clinical Trial 2023: 11UCB-J PET Scan Highlights & Side Effects. Trial Name: NCT03527485 — N/A
11UCB-J PET Scan (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03527485 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age of sixty years or higher preclude individuals from participating in this experiment?

"To participate in this study, participants must be under 55 years of age and have reached the legal age for consent."

Answered by AI

Has the enrollment period for this trial closed yet?

"According to the records found on clinicaltrials.gov, this study is currently in a recruitment phase. Originally posted on January 1st 2019 and last amended on May 20th 2022."

Answered by AI

What criteria must prospective participants satisfy in order to join this experiment?

"This trial calls for 90 participants aged 21 to 55 with an established history of opiate dependency. Additional inclusion criteria includes: a two week cocaine-free period and four weeks free from opiates (verified via urinalysis), voluntary consent, good physical health as confirmed through medical records, diagnosis of Cocaine Use Disorder or Opiate Use Disorder according to DSM-5 standards, negative pregnancy test in females, and average intelligence indicated by the WAIS-IV Full Scale and Verbal IQ scores."

Answered by AI

What is the population size of this research trial?

"Affirmative. Clinicaltrials.gov hosts information indicating that this clinical trial is presently seeking participants, first posted on January 1st 2019 and last updated on May 20th 2022. A total of 90 candidates are required to be recruited from just a single site."

Answered by AI

Who else is applying?

What site did they apply to?
CT Mental Health Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have been addicted to opiates most of my life and am very interested in what my brain looks like and why.
PatientReceived 1 prior treatment
~2 spots leftby Mar 2025