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

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ClinicalTrials.gov Identifier: NCT01108679
Recruitment Status : Unknown
Verified April 2010 by Albert Einstein College of Medicine, Inc..
Recruitment status was:  Recruiting
First Posted : April 22, 2010
Last Update Posted : May 7, 2010
Information provided by:

Study Description
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. 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 or disease
Opioid-Related Disorders Buprenorphine HIV Cognition HIV Infections

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Study Start Date : December 2009
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

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).

Outcome Measures

Primary Outcome Measures :
  1. Global Neurocognitive Function [ Time Frame: Months 3 and 6 ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood, Urine

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108679

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

United States, New York
Fordham University Active, not recruiting
Bronx, New York, United States, 10458
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.         
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Montefiore Medical Center
Fordham University
Principal Investigator: Julia Arnsten, M.D., M.P.H. Albert Einstein College of Medicine, Inc.
More Information

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
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: April 2010

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