Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
Recruitment status was Recruiting
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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 |
|---|
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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 |
- 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 |
|---|
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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 |
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| Contact: Mia Brisbane | (718) 944-3846 | MBRISBAN@montefiore.org |
| Contact: Lauren Sher | (718) 944-3864 | LSHER@montefiore.org |
| 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 | |
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Substance-Related Disorders |
Mental Disorders Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on June 18, 2013