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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV; Cognition; Opioid-related Disorders; Buprenorphine

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10458
      • Fordham University
    • Bronx, New York, United States, 10467
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Buprenorphine; Opioid-dependent drug users who are initiating buprenorphine treatment at the Albert Einstein College of Medicine Division of Substance Abuse (DoSA) or at Montefiore's Comprehensive Health Care Center (CHCC).

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: Montefiore Medical Center; Fordham University
• Investigators: Principal Investigator: Julia Arnsten, M.D., M.P.H., Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2009-471

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes