[18F]FTP PET/CT Imaging for Cocaine Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to understand how the brain's D3 dopamine receptors, which are involved in mood, thought, and addiction, function in individuals with cocaine addiction and healthy volunteers. It employs a special PET/CT scan with a compound called [18F]FTP, a radiotracer used in imaging, to obtain clearer images of these brain receptors. The trial includes different groups: one consists of healthy individuals who may receive either a placebo or a calming medicine called lorazepam before scanning, and another involves those seeking treatment for cocaine addiction. This trial suits males who have been using cocaine regularly and seek help with their addiction, as well as healthy volunteers without major health issues or certain mental health conditions. Participants must have a recent brain MRI or be willing to undergo one for the study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that participants do not use dopaminergic CNS stimulants (medications affecting the central nervous system) within 30 days of screening. Additionally, cocaine-dependent participants cannot be on any psychoactive medications. Other medications may be allowed if they do not interfere with the study, but it's best to discuss your specific medications with the study team.
What prior data suggests that this protocol is safe for imaging D3 receptors in the brain?
Research has shown that [18F]FTP, used in PET/CT scans, has been tested for safety in both animals and humans. In animal studies, researchers used [18F]FTP to track its movement through the body, and no harmful effects were found. In human studies, [18F]FTP is being evaluated for its ability to measure certain brain receptors related to conditions like addiction and some mental health issues.
Previous research using this imaging method has not identified any major safety problems, but ongoing testing aims to ensure its safety for people. As this trial is in the early stages, it primarily focuses on understanding how the treatment works in the body and ensuring participant safety.12345Why are researchers excited about this trial?
Researchers are excited about the [18F]FTP PET/CT imaging trial for cocaine addiction because it explores a novel way to understand brain activity in cocaine-dependent individuals. Unlike traditional treatments that focus on managing withdrawal symptoms or reducing cravings through medication or therapy, this imaging approach aims to provide detailed insights into how cocaine affects the brain at a metabolic level. By using [18F]FTP, a radiotracer, alongside advanced PET/CT scans, researchers hope to map out specific brain changes in cocaine users, offering a clearer picture that could lead to more targeted and effective treatments in the future. This method not only helps in assessing current brain function but also in comparing these findings with healthy individuals, potentially revolutionizing how cocaine addiction is understood and treated.
What evidence suggests that [18F]FTP PET/CT is effective for imaging D3 receptors in cocaine addiction?
Studies have shown that PET imaging, part of the [18F]FTP PET/CT process, effectively detects brain changes related to cocaine addiction. This trial includes several cohorts using [18F]FTP PET/CT to study different aspects of cocaine addiction. For instance, Cohort 3 involves cocaine-dependent males undergoing imaging to determine arterial blood input and FTP parent to metabolite ratio curves. Meanwhile, Cohort 4 examines test/retest variability in cocaine-dependent patients. This imaging method identifies specific brain areas affected by cocaine use, which is crucial for understanding addiction. Research has also shown that brain imaging can monitor changes in brain activity when cocaine use stops. This makes [18F]FTP PET/CT a promising tool for understanding cocaine's impact on the brain and potentially guiding treatment options.23467
Who Is on the Research Team?
Jacob Dubroff, MD, PhD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for healthy males aged 18-60, or those with moderate to severe cocaine use disorder seeking treatment. Participants must be in good health as determined by an investigator and not have significant medical conditions that could affect the study or their safety. Pregnant women, individuals with certain medical conditions like liver disease, epilepsy, or severe respiratory issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Treatment
Participants undergo dynamic [18F]FTP PET/CT brain scans with different interventions (lorazepam, perphenazine, or placebo) and arterial sampling for cocaine-dependent subjects
Test/Retest
Participants undergo test-retest scans to evaluate the variability of [18F]FTP uptake measures
Follow-up
Participants are monitored for safety and effectiveness after imaging procedures
What Are the Treatments Tested in This Trial?
Interventions
- [18F]FTP PET/CT
Trial Overview
[18F]FTP PET/CT scans are being tested to measure D3 dopamine receptor binding in the brain. The study involves healthy volunteers and cocaine-dependent subjects who will receive either lorazepam or a placebo before scanning to assess [18F]FTP uptake variability.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Up to 5 cocaine-dependent males who are voluntarily seeking treatment for cocaine dependence will participate in this imaging cohort. Each subject will undergo two dynamic \[18F\]FTP PET/CT brain scans on two separate days. This group will be used to test the variability of the \[18F\]FTP uptake measures in cocaine-dependent patients when scans are done following the consistent procedures with no other interventions. Subjects in all cohorts are required to have a structural brain MRI performed within 1 year of study enrollment. If the subject has not had a brain MRI that is deemed acceptable for use for this study, they will be asked to undergo a research brain MRI after they have consented for this study.
Up to 5 cocaine-dependent males who are voluntarily seeking treatment for cocaine dependence will participate in this imaging cohort. Each subject will undergo one dynamic \[18F\]FTP PET/CT brain scan. Patients will have an arterial line placed for blood draws during the scan. This group will be used to determine the arterial blood input and FTP parent to metabolite ratio curves for FTP for a cocaine-dependent patient population for comparison with previously collected data in healthy normal volunteers. Subjects in all cohorts are required to have a structural brain MRI performed within 1 year of study enrollment. If the subject has not had a brain MRI that is deemed acceptable for use for this study, they will be asked to undergo a research brain MRI after they have consented for this study.
Up to 10 healthy volunteers will participate in a serial imaging cohort. Each subject will undergo two dynamic \[18F\]FTP PET/CT brain scans on two separate days. Subjects in all cohorts are required to have a structural brain MRI performed within 1 year of study enrollment. If the subject has not had a brain MRI that is deemed acceptable for use for this study, they will be asked to undergo a research brain MRI after they have consented for this study.
Up to 5 healthy volunteers will participate in a double-blind, placebo controlled serial imaging cohort 1a. Each subject will undergo two dynamic \[18F\]FTP PET/CT brain scans on two separate days. On one scan day the patient will receive an IV injection of normal saline (placebo) prior to the FTP brain scan, on the other scan day the patient will receive an IV injection of lorazepam prior to the planned FTP injection scan. The type of injection (placebo versus lorazepam) will be double-blinded to the patient and the injecting nuclear medicine Authorized User. Up to 5 subjects will participate in Cohort 1b where subjects will undergo two FTP PET/CT with and without perphenazine. Subjects in all cohorts are required to have a structural brain MRI performed within 1 year of study enrollment. If the subject has not had a brain MRI that is deemed acceptable for use for this study, they will be asked to undergo a research brain MRI after they have consented for this study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Published Research Related to This Trial
Citations
Fluorodeoxyglucose-Positron Emission Tomography in Rats ...
Biomarkers that are indicative of recreational drug use and addicted behavior are lacking. We performed a translational [18F]-fluorodeoxyglucose-positron ...
Brain Imaging Studies of the Effects of Cocaine Abstinence ...
1. Cocaine abstinent group. Interventions: Radiation: PET scan; Other: fMRI · 2. Normal healthy control group. Interventions: Radiation: PET scan; Other: fMRI.
PET Imaging of the Effects of Age and Cocaine on the ...
Here we report our preliminary studies evaluting the NET in individuals with cocaine dependence (COC) in comparison to healthy controls (HC) using (S,S)-[11C] ...
[18F]FTP PET/CT Imaging for Cocaine Addiction
The research highlights that PET imaging, which is part of the [18F]FTP PET/CT treatment, is effective in identifying brain changes associated with cocaine ...
A prospective 18F-fluorodeoxyglucose positron emission ...
Conclusion: HIV infection and cocaine usage were independently associated with a decrease in brain glucose uptake as measured by 18F-FDG PET/CT.
Study Details | NCT02815917 | Evaluation of D3 Receptor ...
Test-retest scans will evaluate the variability of [18F]FTP uptake measures in both healthy volunteer subjects and cocaine-dependent subjects. Official Title.
specific PET radioligand [18F]FluorTriopride estimated ...
The objective of this study is to deter- mine the organ distribution of [18F]FTP in rodent and nonhuman primate species of animals to estimate ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.