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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108679
• Other study ID #: 2009-471
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Buprenorphine
• Cognition
• HIV
• HIV Infections
• Opioid-Related Disorders

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