CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Methylphenidate Pill +3 moredrug
Likely dose
Methylphenidate Pill 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03326245
NCT03326245Phase 1Completed

Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI

National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Oct 31, 2017·Updated May 28, 2024

In Brief

A Phase 1 clinical trial evaluating Methylphenidate Pill, Oral Placebo, and 2 other interventions for Normal Physiology. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 31, 2017
Enrollment StartJan 29, 2018
Primary CompletionDec 13, 2021
Study CompletionFeb 8, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.7 years ago

Interventions

Methylphenidate Pilldrug

Oral methylphenidate (60 mg) given 30 minutes prior to bolus \[11C\]raclopride

Oral Placebodrug

Oral PL will be given 30 minutes prior to bolus \[11C\]raclopride injection

Intravenous Placebodrug

Intravenous Placebo given 30 minutes post bolus injection of \[11C\]raclopride.

Intravenous methylphenidatedrug

Intravenous methylphenidate 0.25 mg/kg in 3ml sterile saline given 30 minutes post bolus injection of \[11C\]raclopride.