Clinical trial NCT01108679: Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Official title: Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-related Disorders
Buprenorphine
HIV
Cognition
HIV Infections
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
name: Fordham University
First posted: 2010-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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.

Primary outcomes:
measure: Global Neurocognitive Function
timeFrame: Months 3 and 6
measure: Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning
timeFrame: Months 3 and 6
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Fordham University
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Julia Arnsten, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott TM, Rivera Mindt M, Cunningham CO, Arias F, Coulehan K, Mangalonzo A, Olsen P, Arnsten JH. Neuropsychological function is improved among opioid dependent adults who adhere to opiate agonist treatment with buprenorphine-naloxone: a preliminary study. Subst Abuse Treat Prev Policy. 2017 Nov 15;12(1):48. doi: 10.1186/s13011-017-0133-2.