Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users

Completed

Conditions studied: Opioid-related Disorders, Buprenorphine, HIV, Cognition, HIV Infections

In brief

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. This study hypothesizes 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. This study also hypothesizes the biomarkers in participants' blood samples will be associated with measures of change in thinking and reasoning ability.

Key facts

Study ID

NCT01108679

Run by

Albert Einstein College of Medicine

People needed

40

Starts

2009-12-01

Expected to finish

2012-02-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Documented HIV-serostatus
• English-speaking
• Age 18-60
• Able to give voluntary, signed informed consent
• Plan to initiate buprenorphine treatment in the next month.

You may not qualify if…

• 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.

Where it is running

• Fordham University — The Bronx, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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