Human Immunodeficiency Virus Positive or NegativeNCT00245531
Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs
An observational study of Human Immunodeficiency Virus Positive or Negative, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus Positive or Negative
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: males and females 18-50 years old who have completed the 8th grade and are using drugs
Who may be able to join
- Completed the 8th grade
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, The Clinical Trials Unit
Baltimore, Maryland, 21205
About this study
Official title: 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.
Read the 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).
- Keywords
- endocrine abnormalities, cognitive performance
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| +IDU/+HIV or -HIV | Not described | |
| -IDU and -HIV (controls) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus Positive or NegativeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Adrian S. Dobs, Johns Hopkins University
- Investigators
- Adrian S Dobs, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245531
- Sponsor's protocol ID
- 05-01-12-04
- Status last verified
- Mar 2015
- First submitted
- 25 Oct 2005
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37795623Zilbermint 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.
PubMed 23021515
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endocrine Health on the Cognitive Function of Men and Women Using Drugs: A Cross-sectional Investigation
- ClinicalTrials.gov ID
- NCT00245531
- Acronym / sponsor ID
- 05-01-12-04
- Keywords
- endocrine abnormalities, cognitive performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| +IDU/+HIV or -HIV | – | – |
| -IDU and -HIV (controls) | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- males and females 18-50 years old who have completed the 8th grade and are using drugs
Key inclusion criteria (1 listed)
- Completed the 8th grade
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function
Time frame: 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.
1 secondary outcome
Gonadal hormones
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 37795623Goldberg 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.
- Derived from this study: PubMed 23021515Zilbermint 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian S Dobs, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Positive or Negative, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00245531, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.