Neurocognitive Effects of Opiate Agonist Treatment

Description

The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two types of opioid addiction treatment, on the ability to think and reason among people addicted to opiates, and who are either HIV negative or HIV positive; (2) investigate whether HIV infection changes the way opioid treatment affects the ability to think and reason; and (3) collect blood samples to be stored for HIV+ and HIV- individuals to study the effects of buprenorphine and methadone. The investigators hypothesize that there will be (1) significant improvement in thinking and reasoning ability after starting buprenorphine treatment compared to methadone treatment, among participants with and without HIV at 3 and 6 months compared to baseline; (2) 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; and (3) there will be biomarkers in participants' blood samples that will be associated with measures of change in thinking and reasoning ability.

Study Start Date

January 2013

Estimated Completion Date

October 2016

Interventions

  • Drug: Methadone
  • Drug: Buprenorphine

Specialties

  • Psychiatry: Neuro/Psych Pharmacol,Substance Abuse
  • Infectious Disease: HIV/Immunodeficiency
  • Pharmacy: Drug Trials,Neuro/Psych pharmacology

MeSH Terms

  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Opioid-Related Disorders

Study ID

Albert Einstein College of Medicine of Yeshiva University -- 2012-433

Status

Unknown

Trial ID

NCT01733693

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

160

Sponsor

Albert Einstein College of Medicine of Yeshiva University

Inclusion Criteria

  • Age 18
  • 68
  • English or Spanish speaking
  • Documentation of HIV Status
  • Opioid-dependent without having received medication treatment for opioid dependence within the previous 90 days
  • Negative pregnancy test, for women
  • No "street" use of methadone or buprenorphine
  • Willing to participate in all study components
  • Able to provide informed consent
  • Education > 6 years
  • Not acutely intoxicated

Exclusion Criteria

  • Serious or unstable medical disease: liver disease (AST or ALT ? 3x ULN, elevated PT/INR, albumin <3.0 g/dl or evidence of decompensated cirrhosis)
  • Severe cardiovascular disease (MI, PTCA, unstable angina, CABG, and/or serious arrhythmia in the previous 6 months)
  • COPD (requiring supplemental oxygen or hospitalization in past 6 months)
  • End stage renal disease or creatinine clearance <30 mL/min
  • Neurological disease: head injury with LOC>24 hour, previous penetrating skull wound, focal brain lesion, history of neurosurgery, seizure disorder (not ETOH-related), non-HIV CNS opportunistic infection
  • Psychiatric disorders (schizophrenia or bipolar)
  • Benzodiazepine or alcohol dependence
  • Chronic pain conditions requiring opioid analgesics

Gender

Both

Ages

18 Years to 68 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Albert Einstein College of Medicine of Yeshiva University - Bronx, New York 40.3 miles Zohar Massey MPH 718-944-3849 ZMASSEY@montefiore.org
Albert Einstein College of Medicine of Yeshiva University - Bronx, New York 40.3 miles None None None
Fordham University - Bronx, New York 41.5 miles None None None

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