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

Effects of Endocrine Health on the Cognitive Function of Men and Women Using Drugs: A Cross-sectional Investigation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00245531

Enrollment

300

Registered

2005-10-28

Start date

2004-08-31

Completion date

2010-12-31

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus Positive or Negative

Keywords

endocrine abnormalities, cognitive performance

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).

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Quality of life	12 weeks	We intend to examine associations between measures of QOL and the cognitive and endocrine measures described above.

Countries

United States

Outcome results