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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Montefiore Medical Center
Fordham University
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01108679
First received: April 21, 2010
Last updated: May 6, 2010
Last verified: April 2010
  Purpose

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. We hypothesize 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. We also hypothesize that the biomarkers in participants' blood samples will be associated with measures of change in thinking and reasoning ability.


Condition
Opioid-Related Disorders
Buprenorphine
HIV
Cognition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Global Neurocognitive Function [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, Urine


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108679

Contacts
Contact: Mia Brisbane (718) 944-3846 MBRISBAN@montefiore.org
Contact: Lauren Sher (718) 944-3864 LSHER@montefiore.org

Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Mia Brisbane    718-944-3846    MBRISBAN@montefiore.org   
Principal Investigator: Julia Arnsten, M.D., M.P.H.         
Sub-Investigator: Chinazo Cunningham, M.D., M.S.         
Sub-Investigator: Ruth Angeletti, Ph.D.         
Fordham University Active, not recruiting
Bronx, New York, United States, 10458
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
Fordham University
Investigators
Principal Investigator: Julia Arnsten, M.D., M.P.H. Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Dr. Julia Arnsten, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01108679     History of Changes
Other Study ID Numbers: 2009-471
Study First Received: April 21, 2010
Last Updated: May 6, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Opioid-Related Disorders
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 19, 2014