NCT00047866

Brief Summary

This study seeks more information about the biology of substance dependency by exploring the brain areas involved in feeling positive and negative emotions. Specifically, it will determine whether a brain chemical called dopamine affects activity in certain brain regions during performance of a game that involves winning and losing money. Brain activity will be examined using magnetic resonance imaging (MRI), a test that uses a magnetic field and radio waves to produce images of brain structure and function. Young to middle-aged healthy adults may participate in this study. Candidates will be screened with a medical history, physical examination, electrocardiogram (EKG), psychiatric interview, and blood and urine tests. Participants will be assigned to one of the two study procedures, as follows: Tyrosine/Phenylalanine This study requires two overnight stays at the NIH Clinical Center. For each stay, subjects are admitted to the hospital the afternoon before the MRI scan. From the time of admission until after the scan, their diets are restricted to food relatively low in amino acids, prepared by NIH dietitians. The next day, participants undergo MRI scanning. For this procedure, the subject lies on a table that is moved into the scanner, a metal cylindrical machine. Earplugs are worn to muffle loud noises that occur with electrical switching of the radio frequency circuits. Imaging of brain structure takes about 10 to 15 minutes. Additional scans are then taken to measure brain activity while the subject plays simple computer games for money. These scans take about another 20 to 45 minutes. Five hours before the MRI, the subject drinks one of two beverages containing amino acids. A different beverage is given for each of the two visits: one drink lacks the essential amino acids tyrosine and phenylalanine, from which the body makes dopamine; the other contains balanced amounts of these two amino acids. Finally, subjects fill out mood-rating questionnaires before and after drinking each of the beverages. Dextroamphetamine This study requires two outpatient visits to the NIH Clinical Center. For one visit, participants are given an injection of 0.2 mg/kg body weight of the drug dextroamphetamine; for the other, they are given an injection of saline (salt water). After each injection, they undergo MRI scanning while playing computer games for money, as described above. They will fill out mood-rating questionnaires before and after each brain scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2002

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2002

Completed
7.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2010

Completed
Last Updated

July 2, 2017

Status Verified

June 25, 2010

First QC Date

October 22, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

Limbic SystemAmphetamineDopamineBrain ImagingCerebral Blood FlowCerebral Blood VolumeAlcoholismTyrosine DepletionAmino AcidsAffectHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Subjects are physically healthy as determined by medical evaluation at the NIAAA outpatient clinic. In particular, subjects must demonstrate no cardiovascular or blood pressure abnormalities, such as a resting blood pressure of 140/90 or greater. All values of laboratory test must be within the NIH defined normal range and all radiological and cardiac evaluations must be considered normal by the NIH radiologist or cardiologist reading the scan or record. As is usual clinical practice, in the case of minor abnormalities a lab test may be repeated to ensure the validity of the initial report.
  • Are between 18-65 years of age.
  • Have 20/20 vision or wear corrective contact lenses. Plastic glasses with pop-in lenses of different strengths are available in the NMR center for use with nearsighted subjects who do not wear contacts.
  • Test HIV negative.
  • Have no indication of any organic brain syndrome.
  • Do not meet criteria for any present or past Axis I psychiatric disorder, including nicotine dependence. Smokers will be excluded.
  • Have no active homicidal or suicidal ideation, or active symptoms of post-traumatic stress disorder.
  • Are not currently receiving psychotropic medication or medication likely to affect brain neurotransmitter systems.
  • Have no indication of recent drug use as evidenced by urine drug screen and self-report.
  • Are not pregnant or lactating.

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 (3)

  • Holland P, Mushinski M. Costs of alcohol and drug abuse in the United States, 1992. Alcohol/Drugs COI Study Team. Stat Bull Metrop Insur Co. 1999 Oct-Dec;80(4):2-9.

    PMID: 10553265BACKGROUND
  • Koob GF. Neurobiology of addiction. Toward the development of new therapies. Ann N Y Acad Sci. 2000;909:170-85. doi: 10.1111/j.1749-6632.2000.tb06682.x.

    PMID: 10911930BACKGROUND
  • Volkow ND, Wang GJ, Fowler JS, Logan J, Gatley SJ, Hitzemann R, Chen AD, Dewey SL, Pappas N. Decreased striatal dopaminergic responsiveness in detoxified cocaine-dependent subjects. Nature. 1997 Apr 24;386(6627):830-3. doi: 10.1038/386830a0.

    PMID: 9126741BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 22, 2002

First Posted

October 23, 2002

Study Start

October 12, 2002

Study Completion

June 25, 2010

Last Updated

July 2, 2017

Record last verified: 2010-06-25

Locations