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

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Adrian S. Dobs, Johns Hopkins University
ClinicalTrials.gov Identifier:
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of Endocrine Health on the Cognitive Function of Men and Women Using Drugs: A Cross-sectional Investigation

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

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.

Other Outcome Measures:
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We intend to examine associations between measures of QOL and the cognitive and endocrine measures described above.

Estimated Enrollment: 300
Study Start Date: August 2004
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
-IDU and -HIV (controls)

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).


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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


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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00245531

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)
Principal Investigator: Adrian S Dobs, M.D. Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional 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
Study First Received: October 25, 2005
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
endocrine abnormalities
cognitive performance

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

ClinicalTrials.gov processed this record on October 07, 2015