D3 Dopamine ReceptorPhase 1/2NCT02815917
Evaluation of D3 Receptor Occupancy Using FLUORTRIOPRIDE ([18F]FTP) PET/CT
A Phase 1/2 study testing [18F]FTP PET/CT in people with D3 Dopamine Receptor and Cocaine-dependent, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- D3 Dopamine Receptor, Cocaine-dependent, Healthy Volunteer
- What is being tested?
- [18F]FTP PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be 18-60 years of age
- "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)
- 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.
- 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.
Who cannot join
- 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.
- 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
Show all 18Show fewer
- 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
- Positive urine drug screen at the screening intake visit
- Self-reported current alcohol consumption that exceeds greater than 25 drinks per week
- 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
- 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.
- 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
- 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.
- 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 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.
- Currently requires treatment with any psychoactive medications
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of D3 Receptor Occupancy Using [18F]FLUORTRIOPRIDE ([18F]FTP) PET/CT
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.
- Conditions
- D3 Dopamine Receptor, Cocaine-dependent, Healthy Volunteer
- Being tested
- [18F]FTP PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FTP PET/CTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a: Lorazepam; 1b: Perphenazine | Experimental | 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. Receives: Drug: [18F]FTP PET/CT |
| Cohort 2: Healthy Volunteer Test/Retest | Experimental | 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. Receives: Drug: [18F]FTP PET/CT |
| Cohort 3: Arterial sampling | Experimental | 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. Receives: Drug: [18F]FTP PET/CT |
| Cohort 4: Cocaine-dependent Test/Retest | Experimental | 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. Receives: Drug: [18F]FTP PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the difference in uptake [18F]fluortriopride in D3-rich regions in the brain after injection of lorazepam versus placebo in healthy volunteers
Measured: 2 years
Measure test-retest variability of [18F]fluortriopride uptake measures in healthy volunteer subjects and cocaine-dependent subjects
Measured: 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
Measured: 2 years
Secondary outcomes (1)
Correlate standard measures of cocaine craving and withdrawal to [18F]FTP uptake in cocaine-dependent subjects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D3 Dopamine ReceptorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Dubroff, MD PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815917
- Sponsor's protocol ID
- 824853
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2016
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of D3 Receptor Occupancy Using [18F]FLUORTRIOPRIDE ([18F]FTP) PET/CT
- ClinicalTrials.gov ID
- NCT02815917
- Acronym / sponsor ID
- 824853
- Conditions
- D3 Dopamine Receptor, Cocaine-dependent, Healthy Volunteer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a: Lorazepam; 1b: Perphenazine | Experimental | Drug: [18F]FTP PET/CTUp 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. |
| Cohort 2: Healthy Volunteer Test/Retest | Experimental | Drug: [18F]FTP PET/CTUp 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. |
| Cohort 3: Arterial sampling | Experimental | Drug: [18F]FTP PET/CTUp 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. |
| Cohort 4: Cocaine-dependent Test/Retest | Experimental | Drug: [18F]FTP PET/CTUp 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will be 18-60 years of age
- "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)
- 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.
- 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.
Key exclusion criteria (18 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FTP PET/CTAll 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. | Drug | Cohort 1a: Lorazepam; 1b: Perphenazine, Cohort 2: Healthy Volunteer Test/Retest, Cohort 3: Arterial sampling, Cohort 4: Cocaine-dependent Test/Retest |
Primary outcome
Assess the difference in uptake [18F]fluortriopride in D3-rich regions in the brain after injection of lorazepam versus placebo in healthy volunteers
Time frame: 2 years
Measure test-retest variability of [18F]fluortriopride uptake measures in healthy volunteer subjects and cocaine-dependent subjects
Time frame: 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
Time frame: 2 years
1 secondary outcome
Correlate standard measures of cocaine craving and withdrawal to [18F]FTP uptake in cocaine-dependent subjects
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for D3 Dopamine Receptor
Not yet recruitingPhase 1/2
A Positron Emission Tomography (PET) Study to Evaluate Dopamine D2 and D3 Receptor Occupancy by SIPI6398
Schizophrenia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Dubroff, MD PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]FTP PET/CT in people with D3 Dopamine Receptor and Cocaine-dependent, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the difference in uptake [18F]fluortriopride in D3-rich regions in the brain after injection of lorazepam versus placebo in healthy volunteers (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.