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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01108679 |
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Date of registration:
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21/04/2010 |
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Primary sponsor: |
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Public title:
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Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
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Scientific title:
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Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01108679 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Mia Brisbane |
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Address:
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Telephone:
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718-944-3846 |
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Email:
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MBRISBAN@montefiore.org |
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Affiliation:
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Name:
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Mia Brisbane |
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Address:
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Telephone:
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(718) 944-3846 |
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Email:
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MBRISBAN@montefiore.org |
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Affiliation:
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Name:
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Julia Arnsten, M.D., M.P.H. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Albert Einstein College of Medicine of Yeshiva University |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Buprenorphine
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Cognition
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HIV
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HIV Infections
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Opioid-Related Disorders
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Primary Outcome(s)
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Global Neurocognitive Function
[Time Frame: Months 3 and 6]
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Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning
[Time Frame: Months 3 and 6]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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