Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs
This study has been completed.
Information provided by (Responsible Party):
Adrian S. Dobs, Johns Hopkins University
First received: October 25, 2005
Last updated: March 30, 2015
Last verified: March 2015
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.
Human Immunodeficiency Virus Positive or Negative
||Time Perspective: Prospective
||Effects of Endocrine Health on the Cognitive Function of Men and Women Using Drugs: A Cross-sectional Investigation
Primary Outcome Measures:
- Cognitive function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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:
- Gonadal hormones [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
+IDU/+HIV or -HIV
-IDU and -HIV (controls)
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).
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
males and females 18-50 years old who have completed the 8th grade and are using drugs
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245531
|Johns Hopkins University, The Clinical Trials Unit
|Baltimore, Maryland, United States, 21205 |
Johns Hopkins University
||Adrian S Dobs, M.D.
||Johns Hopkins University
No publications provided by Johns Hopkins University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Adrian S. Dobs, Professor of Medicine and Oncology, Johns Hopkins University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 25, 2005
||March 30, 2015
||United States: Institutional Review Board
Keywords provided by Johns Hopkins University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 30, 2015
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases