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

Completed

• Conditions: Human Immunodeficiency Virus Positive or Negative

• Registration Number: NCT00245531
• Lead Sponsor: Johns Hopkins University

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.

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive function	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

Name	Time	Method
Gonadal hormones	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.

Trial Locations

Locations (1)

Johns Hopkins University, The Clinical Trials Unit; 🇺🇸 Baltimore, Maryland, United States