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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01108679

Enrollment

Registered

2010-04-22

Start date

2009-12-01

Completion date

2012-02-01

Last updated

2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results