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

November 14, 2012
November 21, 2012
January 2013
October 2016   (final data collection date for primary outcome measure)
  • 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

Same as current
Complete list of historical versions of study NCT01733693 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neurocognitive Effects of Opiate Agonist Treatment
Neurocognitive Effects of Opiate Agonist Treatment

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opioid-Related Disorders
  • HIV
  • HIV Infections
  • 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.
  • 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.
  • Experimental: Buprenorphine
    Oral sublingual tablet, 8-32 mg per day, administered daily for duration of 6 months
    Intervention: Drug: Buprenorphine
  • Active Comparator: Methadone
    Oral sublingual tablet, 60-100 mg per day, administered daily for duration of 6 months
    Intervention: Drug: Methadone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
October 2016
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 68 Years
Yes
Contact: Zohar Massey, MPH (718) 944-3849 ZMASSEY@montefiore.org
Contact: Julia H. Arnsten, MD, MPH (718) 944-3848 JARNSTEN@montefiore.org
United States
 
NCT01733693
2012-433, 1R01DA032552-01A1
No
Julia H. Arnsten, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
  • National Institute on Drug Abuse (NIDA)
  • Montefiore Medical Center
  • Fordham University
Not Provided
Albert Einstein College of Medicine of Yeshiva University
November 2012

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