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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| +IDU/+HIV or -HIV | |||
| -IDU and -HIV (controls) |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gonadal hormones | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | We intend to examine associations between measures of QOL and the cognitive and endocrine measures described above. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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males and females 18-50 years old who have completed the 8th grade and are using drugs
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| Name | Affiliation | Role |
|---|---|---|
| Adrian S Dobs, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University, The Clinical Trials Unit | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37795623 | Derived | Goldberg CS, Trachtenberg F, William Gaynor J, Mahle WT, Ravishankar C, Schwartz SM, Cnota JF, Ohye RG, Gongwer R, Taylor M, Paridon S, Frommelt PC, Afton K, Atz AM, Burns KM, Detterich JA, Hill KD, Cabrera AG, Lewis AB, Pizarro C, Shah A, Sharma B, Newburger JW; Pediatric Heart Network Investigators. Longitudinal Follow-Up of Children With HLHS and Association Between Norwood Shunt Type and Long-Term Outcomes: The SVR III Study. Circulation. 2023 Oct 24;148(17):1330-1339. doi: 10.1161/CIRCULATIONAHA.123.065192. Epub 2023 Oct 5. | |
| 23021515 |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 12 weeks |
| Derived |
| 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |