[18F]FTP PET/CT Imaging for Cocaine Addiction

Palo Alto (17 mi)

Overseen byJacob Dubroff, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial uses a special imaging substance to see how it attaches to certain brain receptors. It targets both healthy volunteers and people addicted to cocaine. The substance lights up specific brain areas when scanned, showing how well it sticks to these receptors. A specific compound has been shown to play a pivotal role in the reinforcing effects of cocaine.

Eligibility Criteria

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

I am between 18 and 60 years old.

I am a male aged between 18 and 60 years and have a dependence on cocaine.

Exclusion Criteria

I am not pregnant.

I cannot take lorazepam due to adverse reactions.

I do not have serious gallbladder, kidney, or liver disease.

I have never had epilepsy or seizures.

I am not on any psychoactive medications.

I have not used any dopamine-related stimulants in the last 30 days.

Treatment Details

[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.

4Treatment groups

Experimental Treatment

Group I: Cohort 4: Cocaine-dependent Test/RetestExperimental Treatment1 Intervention

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.

Group II: Cohort 3: Arterial samplingExperimental Treatment1 Intervention

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.

Group III: Cohort 2: Healthy Volunteer Test/RetestExperimental Treatment1 Intervention

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.

Group IV: Cohort 1a: Lorazepam; 1b: PerphenazineExperimental Treatment1 Intervention

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.