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

NCT01108679 | Completed DMC

• 1 other identifier: 2009-471
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Documented HIV-serostatus
• English-speaking
• Age 18-60
• Able to give voluntary, signed informed consent
• Plan to initiate buprenorphine treatment in the next month.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Montefiore Medical Center: collaborator
• Fordham University: collaborator

Study Sites (2)

Fordham University

The Bronx, New York, 10458, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 29141650 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Urine

MeSH Terms

Conditions

Opioid-Related Disorders; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Julia Arnsten, M.D., M.P.H.

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., Dept of Medicine

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (2)