Evaluation of D3 Receptor Occupancy Using FLUORTRIOPRIDE ([18F]FTP) PET/CT (NCT02815917) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Evaluation of D3 Receptor Occupancy Using FLUORTRIOPRIDE ([18F]FTP) PET/CT
United States30 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants will be 18-60 years of age
Exclusion criteria
. 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.
. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed in women of child-bearing potential at screening.
. History of contraindications to lorazepam (sensitivity to diazepines, sleep apnea syndrome or severe respiratory insufficiency) as assessed by medical record review and/or self-reported
. History of significant gallbladder, kidney or liver disease as assessed by medical record review and/or self-reported OR total bilirubin \> 1.5 x ULN, ALT or AST \> 3 x ULN or creatinine clearance estimated to be less than 60 ml/min at screening. Subjects with history of cholecystectomy will not be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the difference in uptake [18F]fluortriopride in D3-rich regions in the brain after injection of lorazepam versus placebo in healthy volunteers
Timeframe: 2 years
2
Measure test-retest variability of [18F]fluortriopride uptake measures in healthy volunteer subjects and cocaine-dependent subjects
Timeframe: 2 years
3
Evaluate uptake of [18F]fluortriopride in D3-rich areas of the brain in cocaine-dependent volunteers and compare to uptake in healthy volunteer subjects
. History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported
. History of head trauma, that in the opinion of an investigator may interfere with the uptake of \[18F\]FTP as assessed by medical record review and/or self-reported
. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or psychotic disorder, or substance use disorders, as assessed by medical record review and/or self-reported
. Use of dopaminergic CNS stimulants (prescription, over-the counter or recreational drugs) within 30 days of screening intake visit, as assessed by review of health history form and concomitant medication review at screening intake visit (from medical record and/or self-reported) that are deemed by a physician investigator to have a potential influence on the binding of \[18F\]FTP