Brief Summary
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.
Brief Title
Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Categories
Completion Date
Completion Date Type
Actual
Conditions
Opioid-related Disorders
Buprenorphine
HIV
Cognition
HIV Infections
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* Documented HIV-serostatus
* English-speaking
* Age 18-60
* Able to give voluntary, signed informed consent
* Plan to initiate buprenorphine treatment in the next month.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
60 Years
Minimum Age
18 Years
NCT Id
NCT01108679
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2009-471
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Primary Outcomes
Outcome Measure
Global Neurocognitive Function
Outcome Time Frame
Months 3 and 6
Outcome Measure
Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning
Outcome Time Frame
Months 3 and 6
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Subjects for this study will be drug users with a diagnosis of opioid dependence who are initiating buprenorphine therapy at a DoSA clinic or at the CHCC. The study population is expected to reflect the ethnic composition of the opioid-dependent population in the Bronx. This population is composed of 40% women, and is 24% African-American, 58% Hispanic and 17% Caucasian. Both males and females with opioid dependence who are initiating buprenorphine will be recruited for the proposed study, and, based on our previous studies, we expect to recruit high proportions of women and minorities.
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
60
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Julia Arnsten
Investigator Email
julia.arnsten@einsteinmed.org
Investigator Phone
718-920-6641