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Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs

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ClinicalTrials.gov Identifier: NCT00245531
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to understand the effects of decreased functioning of the testes or ovaries on mental performance in males and females using illicit drugs excluding marijuana.

Condition or disease
Human Immunodeficiency Virus Positive or Negative

Detailed Description:
This research is being done to understand the effects of endocrine abnormalities, specifically hypogonadism (decreased functioning of the testes or ovaries) on cognitive (mental) performance in males and females using illicit drugs (excluding marijuana).

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Effects of Endocrine Health on the Cognitive Function of Men and Women Using Drugs: A Cross-sectional Investigation
Study Start Date : August 2004
Primary Completion Date : June 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
+IDU/+HIV or -HIV
-IDU and -HIV (controls)


Outcome Measures

Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 12 weeks ]
    Performance on visuospatial, fine motor and verbal tasks can be poor in hypogonadal populations of men and women. HIV+ and IDU+ populations often experience endocrine abnormalities such as hypogonadism. The goal of Study 1 is to determine if patterns of cognitive performance associated with hypogonadism generalize to IDU+, HIV+/HIV- populations. Furthermore, an attempt will be made to associate patterns of cognitive performance with specific endocrine measures, IDU status, HIV status and QOL measures. All published testing materials have been shown to provide good reliability.


Secondary Outcome Measures :
  1. Gonadal hormones [ Time Frame: 12 weeks ]
    Serum sex hormone measurements are reliable blood tests commonly used to evaluate gonadal function. Total testosterone, the most frequently used screening test for hypogonadism in men, is relatively inexpensive and reliable; free testosterone is loosely bound to albumin. Levels of LH and FSH will assist in discriminating between a central vs. primary hypogonadism. Estradiol is expected to correlate with testosterone levels in men, since testosterone is aromatized to estradiol in the adipocyte. Based on the literature, it is expected that men and women IDU+ will have centrally mediated (secondary hypogonadism) with decreases in serum FSH, LH, estradiol and androgens.


Other Outcome Measures:
  1. Quality of life [ Time Frame: 12 weeks ]
    We intend to examine associations between measures of QOL and the cognitive and endocrine measures described above.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
males and females 18-50 years old who have completed the 8th grade and are using drugs
Criteria

Inclusion Criteria:

  • Completed the 8th grade

Exclusion Criteria:

  • Did not complete the 8th grade. Have a hormone problem for which you are taking medication e.g. testosterone or thyroid medicine, steroids, oral contraceptives, progesterone. Diagnosed with cancer. History of schizophrenia. Currently have or have been diagnosed in the past with meningitis or encephalitis.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245531


Locations
United States, Maryland
Johns Hopkins University, The Clinical Trials Unit
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Adrian S Dobs, M.D. Johns Hopkins University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adrian S. Dobs, Professor of Medicine and Oncology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00245531     History of Changes
Other Study ID Numbers: 05-01-12-04
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Adrian S. Dobs, Johns Hopkins University:
endocrine abnormalities
cognitive performance

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases