ObesityEarly Phase 1NCT03648892
Brain Dopamine Function in Human Obesity
A Early Phase 1 study testing [c11] raclopride and [18F]fallypride in people with Obesity and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Dopamine is a natural chemical in the brain that may influence eating behavior and physical activity. Researchers want to measure the brain s dopamine activity and understand how it differs in people with obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Healthy Volunteers, Overweight
- What is being tested?
- [c11] raclopride and [18F]fallypride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to 17 Feb 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-45 years, male and female
- Consent to undergoing PET scanning
- Body mass index (BMI) greater than or equal to 18.5 kg/m^2
- Weight stable (less than plus or minus 5% change in the past month)
- Written informed consent
- Estimated intelligence quotient (IQ) greater than or equal to 70, as determined by the National Adult Reading Test (NART) (Scores below 70 are indicative of mental retardation; IQ has been related to alterations in brain structure and function that may confound neuroimaging measures. Failure to meet this eligibility criteria will be documented in the record and communicated to the potential participant as ineligibility based on reading test results )
Who cannot join
- Age 46 or greater (Age is a significant confound in the relationship between BMI and dopamine. Dopamine binding has been shown to drastically decrease in the fifth decade of life.
- Body weight > 400 lbs. (weight limit of PET scanner)
- Weigh less than 80% of maximum lifetime weight
- BMI < 18.5 kg/m2
- Past or present history of neurological or psychiatric disease (e.g., depression, anxiety, substance use disorder or psychosis), or eating disorders (e.g., anorexia nervosa, bulimia nervosa, or binge eating disorder) as determined by research team upon review of history/physical, Eating Disorder Examination-Questionnaire and Self-Rated Level 1 Cross-Cutting Symptom Measure.
- Blood pressure >140/90 mm Hg
Show all 20Show fewer
- Evidence/history of cancer, metabolic disease (e.g. thyroid disease, diabetes) or cardiovascular disease (e.g. coronary artery disease, myocardial infarction, stroke, atherosclerosis), or disease that may influence metabolism
- Current use of prescription medication or other drug that may influence metabolism (diet/weight-loss medication, asthma medication, psychiatric medications such as antidepressants, anti-anxiety medications, and stimulants for attention-deficit/hyperactivity disorder (ADHD), corticosteroids or other medications at the discretion of the PI and/or study team)
- Pregnancy, lactation at any time during study/follow-up period (women only)
- Evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating
- Previous bariatric surgery
- Evidence of nicotine dependence as determined by Fagerstrom score greater than or equal to 3 (including chewing or smoking tobacco), any drug use (amphetamines, cocaine, heroin, marijuana), or problematic alcohol use (i.e. diagnosis of alcohol use disorder: meeting greater than or equal to 2 of 11 criteria in past 12 months, ranging from drinking more/longer than intended to experiencing withdrawal symptoms); report of binge drinking: greater than or equal to 5 drinks in 2 hours or greater than or equal 4 drinks in
- 2 hours for men and women, respectively) over the previous 6 months.
- Volunteers with strict dietary concerns (e.g. kosher diet, milk allergy or lactose intolerance, or food allergies)
- Caffeine consumption > 300 mg/day (roughly greater than or equal to 3 cups coffee or 2-3 energy drinks)
- Having metal implants incompatible with MRI (for example, pacemakers, metallic prostheses such as cochlear implants or heart valves, shrapnel fragments, etc.).
- Having had previous radiation exposure within the last year for either medical or research purposes (e.g. X-rays, PET scans, etc.) that would exceed research limits. Excessive radiation exposure will be determined at the discretion of the PI and/or study team
- Are claustrophobic to a degree that they would feel uncomfortable in the MRI machine.
- Non-English speakers.
- Cannot commit to the schedule of visits to the Clinical Research Center as required by the study timeline
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Dopamine is a natural chemical in the brain that may influence eating behavior and physical activity. Researchers want to measure the brain s dopamine activity and understand how it differs in people with obesity.
Read more
Objective:
To better understand how brain function, particularly dopamine activity, relates to body weight and eating behavior.
Individuals may be able to participate if they:
Have a BMI of at least 18.5 kg/m2
Are weight-stable and generally healthy
Are between ages 18-45 years
Have normal blood pressure
Are not using illegal drugs (based on urine drug screen)
Are not following a special diet
Do not have metal implants
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Questionnaires and an interview to see if it is safe to have a PET/MRI scan
- Fasting blood and urine tests
- Participants will eat a special diet given to them for the 5 days before their inpatient visit.
Participants will have a 5-day inpatient visit. Some days include blood and urine tests. Each day includes surveys and tests to measure habits and likes/dis-likes. A sample schedule may be:
Day 1: Participants will wear a monitor that uses a needle below the skin to measure glucose. Their body fat will be measured with low-dose x-rays
Day 2: Participants will have a PET scan. They will lie on a table that slides in and out of a donut-shaped scanner. They will be injected with a small amount of a radioactive substance and wear a cap on their head.
Day 3: Participants will have an MRI. They will lie on a table that slides in and out of a scanner.
Day 4: Participants will have another PET scan. This time, they will drink a milk shake during a break from the scanner. Then, they will go back inside the scanner for the end of their scan.
Day 5: Participants will wear a hood for up to 40 minutes to measure their breathing. They will also drink special water and collect samples of their urine to measure the rate they burn energy.
For 12 months after the visit, participants will track their weight and physical activity daily using a special scale and activity monitor. A few times over the year, the study team will send participants special activity monitors to use for 7 days at a time.
Participants will have an in-person 1-day follow-up visit. This includes most tests except for PET scanning....
Read the detailed description
Evidence from neuroimaging studies indicates that aberrant functionality in brain regions that support reward processing and habit formation may be related to an individual's eating behavior and obesity propensity. In particular, our previous research found that increased dopamine D2 receptor binding potential (D2BP) in the dorsal and lateral striatum was positively related to opportunistic eating behaviors, body fat, and body mass index (BMI). However, our findings were contrary to highly-cited previous reports of D2BP correlating with BMI in the opposite direction. The primary aim of this study is to elucidate the reasons for the conflicting results that used somewhat different methodologies. Specifically, our previous study used positron emission tomography (PET) to measure D2BP using the dopamine D2 receptor antagonist radioligand [18F]fallypride following a period of dietary stabilization and 3 hours after a standardized breakfast. Reports finding correlations between D2BP and BMI in the opposite direction have typically investigated subjects with higher BMI using the D2 receptor antagonist radioligand [11C]raclopride. Furthermore, previous studies were typically conducted in the fasted state, but the subjects' prior food intake was not well-controlled. The present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride.
- Conditions
- Obesity, Healthy Volunteers, Overweight
- Being tested
- [c11] raclopride, [18F]fallypride
- Keywords
- Dopamine Response, Energy Expenditure, Neurocognitive Function, Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[c11] racloprideDrug
The present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride.
[18F]fallyprideDrug
The present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride.
| Study group | Role | What they receive |
|---|---|---|
| Main | Other | Healthy volunteers, within three BMI strata, under controlled overnight fasting conditions following a period of dietary stabilization Receives: Drug: [c11] raclopride; Drug: [18F]fallypride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Striatal D2 Receptor Binding Potential (D2BP) as Measured by [18F]Fallypride and [11C]Raclopride Time-activity Curves
Correlations between striatal D2BP via [18F]Fallypride and striatal D2BP via [11C]Raclopride is obtained.
Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Measured: assessed at Days 2-5
Relationship Between Striatal D2BP and BMI is Quadratic or Linear
Coefficient estimate of the quadratic term of BMI in quadratic regression is obtained and Coefficient estimate of the linear term of BMI in simple linear regression is obtained.
Measured: assessed at Days 2-5
Change in Striatal Dopamine D2BP After a Palatable Meal
To determine the effect of palatable meal consumption on striatal D2BP using [11C]Raclopride
Measured: assessed at Days 2-5
Correlation Between Change in Striatal Dopamine D2BP After a Palatable Meal and BMI
To determine association between change in striatal dopamine D2BP after a palatable meal consumption and BMI. Binding potential estimates will be estimated within subjects using [11C]Raclopride
Measured: assessed at Days 2-5
Secondary outcomes (3)
Associations Between Behavioral Performance on Food Go/No Go Computer Task and Striatal D2BP
Exploratory analyses of correlations between behavioral performance on Food Go/No Go computer task measured by No Go accuracy as commission errors and striatal D2BP via [18F]Fallypride and via [11C]Raclopride.
Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Measured: assessed at Days 2-5
Associations Between ad Libitum Meal Consumption and Striatal D2 Receptor (D2R)
Exploratory analyses of correlations between eating behavior measured by ad libitum food intake at a single meal and striatal D2R via [18F]Fallypride and via [11C]Raclopride
Measured: assessed at Days 2-5
Associations Between Brain Metabolite GABA Via MRS and Striatal D2BP Via [18F]Fallypride
Exploratory analyses of correlations between brain metabolite GABA via magnetic resonance spectroscopy (MRS) and striatal D2BP via [18F]Fallypride.
Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Measured: assessed at Days 2-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start21 Sep 2018
- Primary completion31 Mar 2022
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Hall, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648892
- Sponsor's protocol ID
- 180132
- Other IDs
- 18-DK-0132
- Status last verified
- May 2022
- First submitted
- 24 Aug 2018
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Darcey VL, Guo J, Chi M, Chung ST, Courville AB, Gallagher I, Herscovitch P, Howard R, La Noire M, Milley L, Schick A, Stagliano M, Turner S, Urbanski N, Yang S, Yim E, Zhai N, Zhou MS, Hall KD. Striatal dopamine tone is positively associated with adiposity in humans as determined by PET using dual dopamine type-2 receptor antagonist tracers. Mol Psychiatry. 2025 Aug;30(8):3708-3717. doi: 10.1038/s41380-025-02960-y. Epub 2025 Apr 6.
PubMed 40188315
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Dopamine Function in Human Obesity
- ClinicalTrials.gov ID
- NCT03648892
- Acronym / sponsor ID
- 180132
- Conditions
- Obesity, Healthy Volunteers, Overweight
- Keywords
- Dopamine Response, Energy Expenditure, Neurocognitive Function, Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Dopamine is a natural chemical in the brain that may influence eating behavior and physical activity. Researchers want to measure the brain s dopamine activity and understand how it differs in people with obesity.
Objective:
To better understand how brain function, particularly dopamine activity, relates to body weight and eating behavior.
Individuals may be able to participate if they:
Have a BMI of at least 18.5 kg/m2
Are weight-stable and generally healthy
Are between ages 18-45 years
Have normal blood pressure
Are not using illegal drugs (based on urine drug screen)
Are not following a special diet
Do not have metal implants
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Questionnaires and an interview to see if it is safe to have a PET/MRI scan
- Fasting blood and urine tests
- Participants will eat a special diet given to them for the 5 days before their inpatient visit.
Participants will have a 5-day inpatient visit. Some days include blood and urine tests. Each day includes surveys and tests to measure habits and likes/dis-likes. A sample schedule may be:
Day 1: Participants will wear a monitor that uses a needle below the skin to measure glucose. Their body fat will be measured with low-dose x-rays
Day 2: Participants will have a PET scan. They will lie on a table that slides in and out of a donut-shaped scanner. They will be injected with a small amount of a radioactive substance and wear a cap on their head.
Day 3: Participants will have an MRI. They will lie on a table that slides in and out of a scanner.
Day 4: Participants will have another PET scan. This time, they will drink a milk shake during a break from the scanner. Then, they will go back inside the scanner for the end of their scan.
Day 5: Participants will wear a hood for up to 40 minutes to measure their breathing. They will also drink special water and collect samples of their urine to measure the rate they burn energy.
For 12 months after the visit, participants will track their weight and physical activity daily using a special scale and activity monitor. A few times over the year, the study team will send participants special activity monitors to use for 7 days at a time.
Participants will have an in-person 1-day follow-up visit. This includes most tests except for PET scanning....
Detailed description
Evidence from neuroimaging studies indicates that aberrant functionality in brain regions that support reward processing and habit formation may be related to an individual's eating behavior and obesity propensity. In particular, our previous research found that increased dopamine D2 receptor binding potential (D2BP) in the dorsal and lateral striatum was positively related to opportunistic eating behaviors, body fat, and body mass index (BMI). However, our findings were contrary to highly-cited previous reports of D2BP correlating with BMI in the opposite direction. The primary aim of this study is to elucidate the reasons for the conflicting results that used somewhat different methodologies. Specifically, our previous study used positron emission tomography (PET) to measure D2BP using the dopamine D2 receptor antagonist radioligand [18F]fallypride following a period of dietary stabilization and 3 hours after a standardized breakfast. Reports finding correlations between D2BP and BMI in the opposite direction have typically investigated subjects with higher BMI using the D2 receptor antagonist radioligand [11C]raclopride. Furthermore, previous studies were typically conducted in the fasted state, but the subjects' prior food intake was not well-controlled. The present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main | Other | Drug: [c11] raclopride, Drug: [18F]fallyprideHealthy volunteers, within three BMI strata, under controlled overnight fasting conditions following a period of dietary stabilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-45 years, male and female
- Consent to undergoing PET scanning
- Body mass index (BMI) greater than or equal to 18.5 kg/m^2
- Weight stable (less than plus or minus 5% change in the past month)
- Written informed consent
Key exclusion criteria (20 listed)
- Age 46 or greater (Age is a significant confound in the relationship between BMI and dopamine. Dopamine binding has been shown to drastically decrease in the fifth decade of life.
- Body weight > 400 lbs. (weight limit of PET scanner)
- Weigh less than 80% of maximum lifetime weight
- BMI < 18.5 kg/m2
- Past or present history of neurological or psychiatric disease (e.g., depression, anxiety, substance use disorder or psychosis), or eating disorders (e.g., anorexia nervosa, bulimia nervosa, or binge eating disorder) as determined by research team upon review of history/physical, Eating Disorder Examination-Questionnaire and Self-Rated Level 1 Cross-Cutting Symptom Measure.
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 |
|---|---|---|
| [c11] racloprideThe present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride. | Drug | Main |
| [18F]fallyprideThe present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride. | Drug | Main |
Primary outcome
Correlation Between Striatal D2 Receptor Binding Potential (D2BP) as Measured by [18F]Fallypride and [11C]Raclopride Time-activity Curves
Time frame: assessed at Days 2-5
Correlations between striatal D2BP via [18F]Fallypride and striatal D2BP via [11C]Raclopride is obtained. Pearson's correlation coefficient is used with a possible range between -1 to 1 indicating strong association in the same direction as correlation is closer to 1, strong association in opposite direction as correlation is closer to -1, and no association as correlation is closer to 0.
Relationship Between Striatal D2BP and BMI is Quadratic or Linear
Time frame: assessed at Days 2-5
Coefficient estimate of the quadratic term of BMI in quadratic regression is obtained and Coefficient estimate of the linear term of BMI in simple linear regression is obtained.
Change in Striatal Dopamine D2BP After a Palatable Meal
Time frame: assessed at Days 2-5
To determine the effect of palatable meal consumption on striatal D2BP using [11C]Raclopride
Correlation Between Change in Striatal Dopamine D2BP After a Palatable Meal and BMI
Time frame: assessed at Days 2-5
To determine association between change in striatal dopamine D2BP after a palatable meal consumption and BMI. Binding potential estimates will be estimated within subjects using [11C]Raclopride
3 secondary outcomes
Associations Between Behavioral Performance on Food Go/No Go Computer Task and Striatal D2BP
Time frame: assessed at Days 2-5
Associations Between ad Libitum Meal Consumption and Striatal D2 Receptor (D2R)
Time frame: assessed at Days 2-5
Associations Between Brain Metabolite GABA Via MRS and Striatal D2BP Via [18F]Fallypride
Time frame: assessed at Days 2-5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40188315Darcey VL, Guo J, Chi M, Chung ST, Courville AB, Gallagher I, Herscovitch P, Howard R, La Noire M, Milley L, Schick A, Stagliano M, Turner S, Urbanski N, Yang S, Yim E, Zhai N, Zhou MS, Hall KD. Striatal dopamine tone is positively associated with adiposity in humans as determined by PET using dual dopamine type-2 receptor antagonist tracers. Mol Psychiatry. 2025 Aug;30(8):3708-3717. doi: 10.1038/s41380-025-02960-y. Epub 2025 Apr 6.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Kevin Hall, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [c11] raclopride and [18F]fallypride in people with Obesity and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 11 Jul 2023. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Between Striatal D2 Receptor Binding Potential (D2BP) as Measured by [18F]Fallypride and [11C]Raclopride Time-activity Curves (time frame: assessed at Days 2-5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648892, which also lists 1 linked publication.
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 11 Jul 2023.