Cocaine-dependent, D3 Dopamine Receptor, Healthy Volunteer
Conditions
Brief summary
Preclinical work suggests that D3 dopamine receptors may be important in the study of the pathophysiology of affective disorders, psychotic disorders and addiction. D3 receptors may also play a role in dystonia, Parkinson's disease and response to treatment of these disorders. However, there has been a lack of specific radioligands for imaging D3 receptors. This proposed protocol will evaluate the uptake of \[18F\]FTP as a more specific in vivo measure of D3 receptor binding in the brain in healthy volunteers subjects after injection of lorazepam vs placebo, and in cocaine-dependent subjects. Test-retest scans will evaluate the variability of \[18F\]FTP uptake measures in both healthy volunteer subjects and cocaine-dependent subjects.
Interventions
DRUG[18F]FTP PET/CT
All PET/CT imaging sessions will include an injection of \[18F\]FTP. Pilot data will be collected to evaluate preliminary information on brain uptake of \[18F\]FTP in healthy volunteers and cocaine-dependent volunteers.
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
for Cohort 1 and 2 (Healthy Volunteers): 1. Participants will be 18-60 years of age 2. "Healthy volunteer" is defined as being in good general health in the opinion of an investigator (controlled diabetes, controlled hypertension or other well controlled chronic medical conditions may be allowed at the discretion of an investigator if they do not believe they will increase patient risk or interfere with the collection of imaging data; specific excluded conditions are described under
Exclusion criteria
) 3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the difference in uptake [18F]fluortriopride in D3-rich regions in the brain after injection of lorazepam versus placebo in healthy volunteers | 2 years |
| Measure test-retest variability of [18F]fluortriopride uptake measures in healthy volunteer subjects and cocaine-dependent subjects | 2 years |
| Evaluate uptake of [18F]fluortriopride in D3-rich areas of the brain in cocaine-dependent volunteers and compare to uptake in healthy volunteer subjects | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Correlate standard measures of cocaine craving and withdrawal to [18F]FTP uptake in cocaine-dependent subjects | 2 years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Dubroff, MD PhD
University of Pennsylvania
Outcome results
None listed