View Clinical Trial (Medical Research Study)
Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
| City: |
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Bronx |
| State: |
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New York |
| Zip Code: |
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10467 |
| Conditions: |
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Opioid-Related Disorders - Buprenorphine - HIV - Cognition - HIV Infections |
| Purpose: |
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The purpose of this study is to examine how Buprenorphine, a form of opioid addiction
treatment, changes the ability to think and reason among people addicted to opiates, who are
either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and
HIV- individuals who take buprenorphine to study its effect. We hypothesize that the HIV
positive participants will demonstrate significant improvement in thinking and reasoning
ability at 3 and 6 months compared to baseline, but that their thinking and reasoning
ability will still be lower than HIV negative participants. We also hypothesize that the
biomarkers in participants' blood samples will be associated with measures of change in
thinking and reasoning ability.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Documented HIV-serostatus
- English-speaking
- Age 18-60
- Able to give voluntary, signed informed consent
- Plan to initiate buprenorphine treatment in the next month.
Exclusion Criteria:
- Over age 60: Participants over the age of 60 will be excluded, as normal
age-associated cognitive changes may confound neuropsychological (NP) assessment and
diagnosis of HIV-related cognitive disorders.
- Neurologic: History of head injury with loss of consciousness for greater than 12
hours; previous penetrating skull wounds; previous brain surgery; known seizure
disorder, or any other non-HIV related CNS disorders that might affect neurocognitive
functioning (e.g., previous cerebrovascular accident, Parkinson's disease, multiple
sclerosis, brain tumor).
- Medical: e.g. collagen vascular disorder (e.g. lupus), oxygen requiring chronic
pulmonary disease,, or end stage renal disease requiring dialysis.
- Psychiatric: Lifetime diagnosis of schizophrenia or bipolar disorder.
- Less than 6 years of education.
- Acute intoxication due to alcohol or other drugs, as assessed by research staff.
- Use of buprenorphine in the past month, either prescribed or purchased on the street.
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| NCT ID: |
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NCT01108679 |
| Primary Contact: |
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Principal Investigator
Julia Arnsten, M.D., M.P.H.
Albert Einstein College of Medicine of Yeshiva University
Mia Brisbane
Phone: (718) 944-3846
Email: MBRISBAN@montefiore.org
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| Backup Contact: |
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Email: LSHER@montefiore.org
Lauren Sher
Phone: (718) 944-3864
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| Location Contact: |
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Bronx, New York 10467
United States
Mia Brisbane
Phone: 718-944-3846
Email: MBRISBAN@montefiore.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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