Neurocognitive Effects of Opiate Agonist Treatment (NEO)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborators:
Montefiore Medical Center
Fordham University
Information provided by (Responsible Party):
Julia H. Arnsten, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01733693
First received: November 14, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Opioid-Related Disorders
HIV
HIV Infections
Drug: Buprenorphine
Drug: Methadone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurocognitive Effects of Opiate Agonist Treatment

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: 3 and 6 months ] [ Designated as safety issue: No ]

    Metrics:

    A Global Deficit Score (GDS) is computed by adding deficit ratings of the component test measures, and dividing by total number of measures. (Please see list of component test measures under the Domain-Specific Neurocognitive Function outcome).


  • Domain-Specific Neurocognitive Function (i.e. in the domains of executive functioning, learning, memory, attention/working memory, processing speed, motor, and verbal functioning). [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

    Metrics:

    Domain Deficit Scores (DDS) are created for each of the 7 cognitive ability domains. Deficit Scores can be analyzed as dichotomous variables to classify individual subjects as impaired or normal, or continuously.

    Executive Functioning -- Wisconsin Card Sorting Task-64 Item Version; Trail Making Test (Part B)

    Learning -- Hopkins Verbal Learning Test-Revised (Total Recall); Brief Visuospatial Memory Test-Revised (Total Recall)

    Memory -- Hopkins Verbal Learning Test (Delayed Recall Trial); Brief Visuospatial Memory Test-Revised (Delayed Recall Trial)

    Attention/Working Memory -- WAIS-III Letter Number Sequencing; PASAT Total Correct

    Processing Speed -- WAIS-III Digit Symbol; WAIS-III Symbol Search; Trail Making Test (Part A)

    Motor -- Grooved Pegboard Time (dominant hand); Grooved Pegboard Time (non-dominant hand)]

    Verbal Functioning -- Controlled Oral Word Association Test (F-A-S); Semantic (Animal) Fluency



Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine
Oral sublingual tablet, 8-32 mg per day, administered daily for duration of 6 months
Drug: Buprenorphine
Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator). We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.
Active Comparator: Methadone
Oral sublingual tablet, 60-100 mg per day, administered daily for duration of 6 months
Drug: Methadone
Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator). We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01733693

Contacts
Contact: Zohar Massey, MPH (718) 944-3849 ZMASSEY@montefiore.org
Contact: Julia H. Arnsten, MD, MPH (718) 944-3848 JARNSTEN@montefiore.org

Locations
United States, New York
Albert Einstein College of Medicine of Yeshiva University Not yet recruiting
Bronx, New York, United States, 10467
Contact: Zohar Massey, MPH    718-944-3849    ZMASSEY@montefiore.org   
Contact: Julia H. Arnsten, MD, MPH    (718) 944-3848    JARNSTEN@montefiore.org   
Principal Investigator: Julia H. Arnsten, MD, MPH         
Sub-Investigator: Chinazo Cunningham, MD, MS         
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
  More Information

No publications provided

Responsible Party: Julia H. Arnsten, Principal Investigator, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01733693     History of Changes
Other Study ID Numbers: 2012-433, 1R01DA032552-01A1
Study First Received: November 14, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Buprenorphine
Methadone
Cognition

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
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Methadone
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
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 11, 2014