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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Adrian S. Dobs, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00245531
First received: October 25, 2005
Last updated: March 30, 2015
Last verified: March 2015

October 25, 2005
March 30, 2015
August 2004
June 2010   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00245531 on ClinicalTrials.gov Archive Site
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.
Not Provided
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.
Not Provided
 
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

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.

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).

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

males and females 18-50 years old who have completed the 8th grade and are using drugs

Human Immunodeficiency Virus Positive or Negative
Not Provided
  • +IDU/+HIV or -HIV
  • -IDU and -HIV (controls)
Zilbermint MF, Wisniewski AB, Xu X, Selnes OA, Dobs AS. Relationship between sex hormones and cognitive performance in men with substance use. Drug Alcohol Depend. 2013 Mar 1;128(3):250-4. doi: 10.1016/j.drugalcdep.2012.08.024. Epub 2012 Sep 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245531
05-01-12-04
Yes
Adrian S. Dobs, Johns Hopkins University
Johns Hopkins University
National Institutes of Health (NIH)
Principal Investigator: Adrian S Dobs, M.D. Johns Hopkins University
Johns Hopkins University
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP