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

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.

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Key information

Conditions

Opioid-related Disorders Blood-Borne Infections Buprenorphine Chemically-Induced Disorders Cognition Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Narcotic-Related Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Albert Einstein College of Medicine, The Bronx, New York, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Global Neurocognitive Function

Time frame: Months 3 and 6
Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning

Time frame: Months 3 and 6

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

Fordham University
Montefiore Medical Center

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Apr 22, 2010
Registry last updated: Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed