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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Pennsylvania

Must not be taking: Dopaminergic stimulants, Psychoactive medications

Disqualifiers: Pregnancy, Epilepsy, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment [18F]FTP PET/CT 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 addiction, such as decreased dopamine receptor availability and altered brain metabolism. This suggests that PET imaging can be a valuable tool in understanding and potentially guiding treatment for cocaine addiction. ^{1 2 3 4 5}

How does [18F]FTP PET/CT Imaging for Cocaine Addiction differ from other treatments?

This treatment is unique because it uses PET/CT imaging to study brain function and structure in cocaine addiction, focusing on dopamine system changes, which is not a standard approach for treating addiction. Unlike typical treatments that might involve medication or therapy, this method provides detailed insights into brain activity and could guide the development of new interventions. ^{1 2 3 4 5}

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.

Research Team

Jacob Dubroff, MD, PhD

Principal Investigator

University of Pennsylvania

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

I primarily use cocaine by smoking it.

Participants for Cohort 3 and 4 (cocaine-dependent) must have moderate to severe cocaine use disorder based on DSM-5 criteria

Exclusion Criteria

I have not had a head injury that affects brain scans.

I am not pregnant.

I cannot take lorazepam due to adverse reactions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

2 days per participant

2 visits (in-person)

Test/Retest

Participants undergo test-retest scans to evaluate the variability of [18F]FTP uptake measures

2 days per participant

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

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.

Participant Groups

Group I: Cohort 4: Cocaine-dependent Test/Retest Experimental Treatment 1 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 sampling Experimental Treatment 1 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/Retest Experimental Treatment 1 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: Perphenazine Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

Neuroimaging has revealed that cocaine dependence affects not only dopamine-rich areas in the brain but also disrupts cortical regions, indicating a more complex network of brain dysfunction in addiction.

Recent studies suggest that changes in functional connectivity in cocaine users are linked to structural brain abnormalities, highlighting the potential for neuroimaging to inform personalized treatment strategies for addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of brain imaging to elucidate neural circuit changes in cocaine addiction. Hanlon, CA., Canterberry, M.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

[Neuroimaging and cocaine: mapping dependence?]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Decreased dopamine D2 receptor availability is associated with reduced frontal metabolism in cocaine abusers. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

The use of brain imaging to elucidate neural circuit changes in cocaine addiction. [2021]

4. England pubmed.ncbi.nlm.nih.gov

White matter integrity is associated with treatment outcome measures in cocaine dependence. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Brain imaging studies of cocaine abuse: implications for medication development. [2019]