[11C]APP311 for Cannabis Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether abstaining from cannabis for at least four weeks can improve brain function, particularly in areas related to memory. Researchers compare individuals with cannabis use disorder to non-users to identify differences in brain activity and memory changes. The study targets daily cannabis users who are willing to quit for the trial's duration. Participants will undergo brain scans using [11C]APP311, a radiotracer used in imaging, to track changes. As an Early Phase 1 trial, this research aims to understand how a cannabis break affects brain function, offering participants the opportunity to contribute to groundbreaking insights.
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.
What prior data suggests that [11C]APP311 is safe for use in humans?
Research has shown that [11C]APP311 is being tested for safety and effectiveness in people with cannabis use disorder. Results so far suggest that [11C]APP311 is generally well-tolerated, with most participants not experiencing serious side effects.
The goal of using [11C]APP311 is to understand changes in the brain's synaptic density, which are the connections between nerve cells, in individuals who have stopped using cannabis. In earlier studies, [11C]APP311 examined brain activity in other conditions and did not show major negative effects.
As this is an early-phase study, the main focus is to ensure the treatment's safety for humans. Although detailed safety information is limited, researchers are closely monitoring for any potential issues. This phase is crucial to ensure the treatment's safe use in larger groups in the future.12345Why are researchers excited about this trial?
Researchers are excited about [11C]APP311 for Cannabis Use Disorder because it offers a novel approach by using a radiolabeled compound in PET scans to explore brain activity associated with cannabis use. Unlike traditional treatments that primarily focus on behavioral therapy or medications like naltrexone or bupropion, this method aims to provide deeper insights into the brain's response to cannabis, potentially leading to more targeted interventions. By highlighting specific brain areas affected by cannabis use, [11C]APP311 could pave the way for developing new, more effective treatments for those struggling with cannabis addiction.
What evidence suggests that [11C]APP311 is effective for cannabis use disorder?
Studies have shown that cannabis use can reduce the number of connections between brain cells in the hippocampus, a region important for memory. This is where [11C]APP311 plays a role. This special imaging tool measures these changes in the brain. Early research suggests that it can help scientists observe how these connections change in individuals with cannabis use disorder. In this trial, researchers will scan participants in the CUD Group using [11C]APP311 to observe these brain changes. Although direct evidence on [11C]APP311's effectiveness in treating cannabis use disorder is limited, its ability to reveal brain changes might enhance understanding of the condition. This could eventually lead to new treatments that improve brain function in cannabis users.678910
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