Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI

NCT03326245 · View on ClinicalTrials.gov ↗

Study Summary

Background: Dopamine (DA) is a chemical signal in the brain linked to learning, memory, and habits. Stimulant drugs like methylphenidate can increase DA in the brain. Researchers want to measure DA with and without this drug. They want to learn how methylphenidate and brain dopamine affect body responses, mood, and thinking. Objective: To better understand the role of dopamine in the brain and the effects of methylphenidate. Eligibility: Adults ages 18-55 who have used alcohol or stimulant drugs but have no drug dependence. Design: Participants will be screened with: * Physical exam * Question about medical, psychiatric, and alcohol and drug use history * Questions to see if it s safe to have a PET/MRI scan * Blood and urine tests * Breath test for alcohol Participants will have 3 or 4 study visits. At each visit they will have: * Urine and breath tested for alcohol and drugs * A thin plastic tube (catheter) inserted in each arm by needle * A small amount of radioactive chemical injected through the catheter. * PET/MRI scan. Participants will lie still on a table that slides in and out of a metal cylinder surrounded by a strong magnetic field. Their vital signs will be monitored. They will get earmuffs for loud noises. Before the scan, participants will get the study drug or placebo through the catheter. They may also get a sugar pill (placebo). They will get a small meal and have blood drawn. * Tests of memory, attention, and thinking. Participants will wear an activity monitor on the wrist for one week.

Conditions Studied

Interventions

  • DRUG Oral Placebo
  • DRUG Intravenous Placebo
  • DRUG Methylphenidate Pill
  • DRUG Intravenous methylphenidate

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center — Bethesda

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2018-01-29
Est. Completion 2024-02-08
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03326245

The ClinicalTrials.gov registry entry for NCT03326245 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Normal Physiology appearing as the primary indexed condition, and to 4 interventions — of which Oral Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03326245 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03326245 about?

NCT03326245 is a clinical study titled "Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI". Background: Dopamine (DA) is a chemical signal in the brain linked to learning, memory, and habits. Stimulant drugs like methylphenidate can increase DA in the brain. Researchers want to measure DA with and without this drug. They want to learn how methylphenidate and brain dopamine affect body res...

What is the current status of trial NCT03326245?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2018-01-29. Estimated completion is 2024-02-08.

What conditions does trial NCT03326245 study?

This clinical trial studies the following conditions: Normal Physiology. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03326245?

The interventions under investigation include: Oral Placebo (DRUG), Intravenous Placebo (DRUG), Methylphenidate Pill (DRUG), Intravenous methylphenidate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03326245?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03326245 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial