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

Study Overview
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Brief Summary
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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. 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.

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

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

Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Buprenorphine<br>Opioid-dependent drug users who are initiating buprenorphine treatment at the Albert Einstein College of Medicine Division of Substance Abuse (DoSA) or at Montefiore's Comprehensive Health Care Center (CHCC). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Neurocognitive Function |  | Months 3 and 6 | 
| Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning |  | Months 3 and 6 |