A new eye on the brain: could this tracer unlock Addiction's secrets?
NCT ID NCT02815917
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study tests a new imaging tracer called [18F]fluortriopride to see if it can clearly show D3 dopamine receptors in the brain. Researchers will compare brain scans from healthy volunteers and people with cocaine dependence, and also check how consistent the tracer's signals are across repeated scans. The goal is to develop a better tool for studying brain conditions like addiction and other disorders linked to dopamine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]fluortriopride ([18F]FTP), a radioactive tracer used for PET/CT brain imaging
- What this could lead to
- If successful, this could provide a reliable way to visualize D3 receptors in the living brain, potentially aiding research into addiction, mood disorders, and Parkinson's disease.
- What could go wrong
- This is an early-phase imaging study with a small number of participants, so results may not be conclusive. The tracer's effectiveness and safety are still being tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
-
Jun 2016
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Exclusion Criteria for Cohort 1 and 2 (Healthy Volunteers) 1. 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. 2. 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 3. 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. 4. History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported 5. 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 6. 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 7. 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 8. Positive urine drug screen at the screening intake visit 9. Self-reported current alcohol consumption that exceeds greater than 25 drinks per week 10. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study 11. Participants with self-reported current nicotine dependence will be excluded. Participants with self-reported history of nicotine use but who report no use within at least 3 months prior to study enrollment will be eligible for the study if they have a negative urine dipcard test for nicotine/cotinine at screening. Inclusion criteria for Cohort 3 and 4 (cocaine-dependent) 1, Participants will be males 18-60 years of age 2. Cocaine-dependent (moderate to severe cocaine use disorder, based on DSM-5 criteria), voluntarily seeking treatment for cocaine dependence 3. Smoking is they self-reported primary route of cocaine administration 4. In the past 30 days, no less than $100-worth of cocaine was used by self-report 5. 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. Exclusion criteria for Cohort 3 and 4 (cocaine-dependent) 1. Meets DSM-5 criteria for moderate to severe substance use disorder for any substance other than cocaine, alcohol, marijuana or nicotine as determined by semi-structured interview. Patients with comorbid alcohol use disorder will be accepted if their alcohol use disorder is not severe enough to require a medicated alcohol detoxification per standard UPHS policies 2. 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. 3. History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported 4. 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 5. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or psychotic disorder as assessed by medical record review and/or self-reported. History of unipolar depression or anxiety disorder may be accepted; current depression or anxiety may be accepted if the severity does not require psychoactive medication. 6. Currently requires treatment with any psychoactive medications 7. Any current medical condition, psychiatric disorder, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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