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
|Condition or disease|
|Human Immunodeficiency Virus Positive or Negative|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2010|
|+IDU/+HIV or -HIV|
|-IDU and -HIV (controls)|
- 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.
- 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.
- Quality of life [ Time Frame: 12 weeks ]We intend to examine associations between measures of QOL and the cognitive and endocrine measures described above.
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
|United States, Maryland|
|Johns Hopkins University, The Clinical Trials Unit|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Adrian S Dobs, M.D.||Johns Hopkins University|