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Radiopharmaceutical

[11C]APP311 for Cannabis Use Disorder

Phase < 1
Recruiting
Led By Deepak C D'Souza
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 8 cud participants will be asked to return for a third [11c]app311 (ucb-j) pet scan after an additional 4 weeks following their second scan. (8 weeks in total).
Awards & highlights

Study Summary

This trial is looking at whether people with cannabis use disorder (CUD) have improved hippocampal function after 4 weeks of confirmed abstinence from cannabis, compared to healthy controls (HC). Changes in synaptic vesicle density will be related to measures of cannabis exposure, like age of initiation and lifetime dose.

Who is the study for?
This trial is for men and women aged 18-75 with moderate to severe cannabis use disorder, who are physically healthy and not using other drugs. They must be willing to attempt quitting cannabis, agree to birth control if applicable, and have no metal implants that could interfere with MRI scans or a history of significant medical conditions.Check my eligibility
What is being tested?
The study tests whether stopping cannabis improves brain function related to memory by measuring changes in hippocampal synaptic vesicle density using [11C]APP-311/[11C]UCB-J binding. It compares individuals with CUD abstaining from cannabis for at least 4 weeks against healthy controls.See study design
What are the potential side effects?
[11C]APP-311/[11C]UCB-J is used for imaging purposes; the side effects are minimal but may include discomfort during the PET scan procedure or reactions related to lying still in the scanner for those who might feel claustrophobic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 8 cud participants will be asked to return for a third [11c]app311 (ucb-j) pet scan after an additional 4 weeks following their second scan. (8 weeks in total).
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 8 cud participants will be asked to return for a third [11c]app311 (ucb-j) pet scan after an additional 4 weeks following their second scan. (8 weeks in total). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hippocampal SV2A synaptic density
Secondary outcome measures
Hippocampal binding and Groton Maze Learning in CUDs
Hippocampal binding and Hippocampal Verbal Memory Task
Other outcome measures
Hippocampal SV2A synaptic density after 8 weeks
Hippocampal synaptic density and cumulative lifetime cannabis exposure.
Hippocampal synaptic density and first age of cannabis exposure

Trial Design

2Treatment groups
Active Control
Group I: CUD GroupActive Control1 Intervention
Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. CUD participants will be asked to abstain from cannabis for the 4 week period.
Group II: Healthy ControlsActive Control1 Intervention
Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart.

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Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,399 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,367 Total Patients Enrolled
Deepak C D'SouzaPrincipal InvestigatorYale University

Media Library

[11C]APP311 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05472818 — Phase < 1
Cannabis Use Disorder Research Study Groups: CUD Group, Healthy Controls
[11C]APP311 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472818 — Phase < 1
Cannabis Use Disorder Patient Testimony for trial: Trial Name: NCT05472818 — Phase < 1

Frequently Asked Questions

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

Are there any remaining vacancies in this clinical trial?

"According to clinicaltrials.gov, this research trial is currently accepting participants. It was initially announced on May 1st 2022 and has recently been updated on October 6th 2022."

Answered by AI

To what extent are individuals participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov has data which confirms that this medical trial is currently accepting participants. The study was originally listed on May 1st 2022, and the most recent edit occurred October 6th 2022; 42 individuals need to be recruited from a single site."

Answered by AI

Is it possible for me to take part in this research?

"To meet the criteria for this study, interested participants must be in good health and between 18-75 years old. The total number of eligible individuals is 42."

Answered by AI

Does this clinical trial include individuals of all ages, or is it limited to those over 50?

"Aged 18 or above and younger than 75, this trial is enlisting volunteers."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
Ohio
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Yale University School of Medicine
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been experiencing CHS for some years now, and looking forward to finally finding out more information about the condition and side effects of THC in some people, and how the results of not using can benefit my lifestyle, and to prevent future THC consumption getting to know the side effects.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
SV2A Density Cannabis Use Disorder
Deepak C. D'Souza 2022. "SV2A Density Cannabis Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05472818.
~25 spots leftby May 2027
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