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

Phase 1 & 2

Waitlist Available

Led By Jacob Dubroff, MD PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants for Cohort 1 and 2 (Healthy Volunteers) must be 18-60 years of age

Participants for Cohort 3 and 4 (cocaine-dependent) must be males aged 18-60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will study the effects of lorazepam on the binding of [18F]FTP to D3 dopamine receptors in the brain in healthy volunteers and in cocaine-dependent subjects, in order to assess the potential of [18F]FTP as a more specific in vivo measure of D3 receptor binding.

Who is the study for?

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.Check my eligibility

What is being tested?

[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.See study design

What are the potential side effects?

Potential side effects may include reactions related to lorazepam such as drowsiness, sedation, unsteadiness, memory problems, and withdrawal symptoms after stopping the drug abruptly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the difference in uptake [18F]fluortriopride in D3-rich regions in the brain after injection of lorazepam versus placebo in healthy volunteers

Evaluate uptake of [18F]fluortriopride in D3-rich areas of the brain in cocaine-dependent volunteers and compare to uptake in healthy volunteer subjects

Cocaine

Secondary outcome measures

Correlate standard measures of cocaine craving and withdrawal to [18F]FTP uptake in cocaine-dependent subjects

Trial Design

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,058 Total Patients Enrolled

Jacob Dubroff, MD PhDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

[18F]FTP PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT02815917 — Phase 1 & 2

Dopamine Receptor Research Study Groups: Cohort 1a: Lorazepam; 1b: Perphenazine, Cohort 3: Arterial sampling, Cohort 4: Cocaine-dependent Test/Retest, Cohort 2: Healthy Volunteer Test/Retest

Dopamine Receptor Clinical Trial 2023: [18F]FTP PET/CT Highlights & Side Effects. Trial Name: NCT02815917 — Phase 1 & 2

[18F]FTP PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT02815917 — Phase 1 & 2

Frequently Asked Questions

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

Does this experiment have an age requirement, and if so, what is the cutoff?

"For this trial, applicants must meet the eligibility criteria of being between 18 to 60 years old. For those not meeting these age requirements, there are fifty trials available for minors and 372 studies open to seniors."

Answered by AI

Does this medical experiment offer enrollment opportunities for me?

"To join this research study, individuals must be dependent on cocaine and have an age that falls between 18-60. Around 30 participants are being accepted into the clinical trial."

Answered by AI

Are any new participants being sought for this clinical experiment?

"Contrary to what is listed on clinicaltrials.gov, this medical study is not currently recruiting any participants. It's initial post date was June 1st 2016 and the most recent update occurred on July 5th 2022. Despite being inactive presently, there are a total of 840 other studies actively searching for individuals at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of D3 Receptor Occupancy Using FLUORTRIOPRIDE ([18F]FTP) PET/CT

2016. "Evaluation of D3 Receptor Occupancy Using FLUORTRIOPRIDE ([18F]FTP) PET/CT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02815917.