PET Imaging of DHA Metabolism

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00074503
• Date of registration: 12/12/2003
• Primary sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Public title: PET Imaging of DHA Metabolism
• Scientific title: Positron Emission Tomography Imaging of Incorporation of Docosahexaenoic Acid (DHA) From Plasma Into Human Brain
• Date of first enrolment: December 2003
• Target sample size: 85
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00074503
• Study type: Observational
• Study design: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Age 18-65 years.

EXCLUSION CRITERIA:

1. Any Axis I diagnosis, current or past.

2. History of any intravenous drug use, or a DSM IV diagnosis of drug use or alcohol
abuse or dependence.

3. Recent use (within the past two weeks) of alcohol, or any period of extensive use,
defined as an average of one standard drink per day over a twelve-month period.

4. Abnormal laboratory or diagnostic tests that might disturb the dependent measures of
the study.

5. Inability to give a clinical history or informed consent.

6. Inability to follow dietary guidelines.

7. Serious medical problems requiring ongoing treatment (i.e., diabetes or
hypertension).

8. Positive test for hepatitis C or human immunodeficiency virus (HIV).

9. Metallic foreign bodies lodged in the head or neck that would be affected by the MRI
scanner magnet.

10. Head trauma resulting in a period of unconsciousness lasting longer than one hour.

11. History of central nervous system infection.

12. History of fetal alcohol syndrome or other neurodevelopment disorder.

13. History of seizures, other than in childhood and related to fever.

14. Nursing women, women with a positive pregnancy test or women of childbearing age who
are not willing to use some form of birth control during the study.

15. Recent exposure to radiation (i.e., PET from other research) which when combined with
this study would be above the allowable limits of exposure.

16. Current use of cigarettes, cigars, or other form of tobacco, defined as ten
cigarettes, two pipes or two cigars over the preceding month.

17. Current drug or medication use, or the use of any medication (i.e., Tylenol) for
three days prior to PET.

18. Positive urine drug screen.

19. Psychotropic medication use (including benzodiazepines and illicit drugs) during the
two weeks prior to the PET scan. The use of medication with a very long half life
(i.e., Prozac) during the six weeks prior to the PET scan.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Secondary ID(s)

04-AA-0058

040058

Source(s) of Monetary Support

Please refer to primary and secondary sponsors