[11C]APP311 for Cannabis Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal \[11C\]APP-311/\[11C\]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal \[11C\]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.
Will I have to stop taking my current medications?
The trial requires that participants do not take medications that could alter synaptic density, as these could affect the study results. If you are on such medications, you may need to stop taking them to participate.
How does the drug [11C]APP311 differ from other treatments for Cannabis Use Disorder?
[11C]APP311 is unique because it is a radioligand used in imaging studies to measure the availability of CB1 receptors in the brain, which are affected by cannabis use. This approach is different from typical treatments as it focuses on understanding the brain's receptor changes rather than directly treating the disorder.12345
Who Is on the Research Team?
Deepak C D'Souza
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline MRI and PET scans and cognitive assessments
Abstinence and Monitoring
CUD participants abstain from cannabis for 4 weeks, with PET scans and cognitive assessments before and after abstinence
Extended Monitoring
A subset of CUD participants undergoes additional PET scan after 8 weeks of abstinence
Follow-up
Participants are monitored for any long-term changes in synaptic density and cognitive function
What Are the Treatments Tested in This Trial?
Interventions
- [11C]APP311
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator