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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01108679
Other study ID # 2009-471
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2009
Est. completion date February 1, 2012

Study information

Verified date April 2019
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 1, 2012
Est. primary completion date February 1, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Locations

Country Name City State
United States Albert Einstein College of Medicine Bronx New York
United States Fordham University Bronx New York

Sponsors (3)

Lead Sponsor Collaborator
Albert Einstein College of Medicine Fordham University, Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global Neurocognitive Function Months 3 and 6
Primary Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning Months 3 and 6
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