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NCT03326245 · ClinicalTrials.gov registry record · Phase 1

Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI

A Phase 1 study of Normal Physiology, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT03326245 is a Phase 1 study of Normal Physiology that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 25 participants, below the 1,292-participant average among 25 other Normal Physiology trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03326245, a Phase 1 study of Normal Physiology, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target
1
Study location

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

Normal Physiology

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

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

93 total trials

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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, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,292-participant average among 25 other Normal Physiology trials with a reported enrollment target (98% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.

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.

NCT03326245 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

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.

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).

Who is sponsoring clinical trial NCT03326245?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.