NCT00062946

Brief Summary

The purpose of this study is to measure molecules on or in cells that interact with a chemical in the nervous system, called dopamine. Investigators will obtain two kinds of images of the brain-a position emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Thirty-eight participants aged 18 to 45 will be enrolled in this study. They must have no history of medical or psychiatric illness, including substance abuse. Participants will have four appointments at NIH. On the first visit, they will undergo a physical exam, a medical history, and lab tests. The second and third visits will involve PET scans and the fourth visit will involve an MRI scan. Participants will be compensated up to $430 for their involvement in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2003

Completed
Same day until next milestone

Study Start

First participant enrolled

June 17, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2003

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2007

Completed
Last Updated

July 2, 2017

Status Verified

August 15, 2007

First QC Date

June 17, 2003

Last Update Submit

June 30, 2017

Conditions

Keywords

ThalamusCerebral CorticesQuantificationReproducibilityDopamine Release(18F) FallyprideD-AmphetamineAlpha-Methyl-Para-Tyrosine (AMPT)PETDopamine D2 ReceptorHealthy VolunteerHV

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45, inclusive
  • In good general health on basis of history and physical examination
  • Normal screening laboratory studies including thyroid function tests, blood count, serum electrolytes, liver and kidney function, and urinalysis
  • Normal ECG at a resting condition
  • Normal blood pressure
  • No illegal drug use based on urine drug screen

You may not qualify if:

  • Pregnancy/Nursing
  • Evidence of active mental or neurological illness
  • Medically significant biochemical or hematological abnormality on screening laboratory studies
  • Abnormal ECG
  • High Blood Pressure (above 140 systolic and/or above 90 dystolic pressure)
  • History of myocardial infarction or angina pectoris
  • Positive urine drug screen or use of alcohol within one week prior to each PET study
  • History of substance abuse or dependence within 6 months
  • Presence of ferromagnetic metal in the body or heart pacemaker
  • Body weight more than 93 kg to limit AMPT dose to 4 g/ day (only for subjects having four PET scans and d-amphetamine and AMPT administration)
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Anand A, Verhoeff P, Seneca N, Zoghbi SS, Seibyl JP, Charney DS, Innis RB. Brain SPECT imaging of amphetamine-induced dopamine release in euthymic bipolar disorder patients. Am J Psychiatry. 2000 Jul;157(7):1108-14. doi: 10.1176/appi.ajp.157.7.1108.

    PMID: 10873919BACKGROUND

MeSH Terms

Interventions

N-((1-allyl-2-pyrrolidinyl)methyl)-5-(3-fluoropropyl)-2,3-dimethoxybenzamide

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

June 17, 2003

First Posted

June 18, 2003

Study Start

June 17, 2003

Study Completion

August 15, 2007

Last Updated

July 2, 2017

Record last verified: 2007-08-15

Locations