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

April 21, 2010
May 6, 2010
December 2009
February 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01108679 on ClinicalTrials.gov Archive Site
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Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
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. 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, Urine

Non-Probability Sample

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.

  • Opioid-Related Disorders
  • Buprenorphine
  • HIV
  • Cognition
  • HIV Infections
Not Provided
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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact: Mia Brisbane (718) 944-3846 MBRISBAN@montefiore.org
Contact: Lauren Sher (718) 944-3864 LSHER@montefiore.org
United States
 
NCT01108679
2009-471
Yes
Dr. Julia Arnsten, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
  • Montefiore Medical Center
  • Fordham University
Principal Investigator: Julia Arnsten, M.D., M.P.H. Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP