Trial record 7 of 21 for: " October 17, 2012":" November 16, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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Neurocognitive Effects of Opiate Agonist Treatment (NEO)

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Albert Einstein College of Medicine of Yeshiva University

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

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: August 4, 2016

Last verified: August 2016

History of Changes

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; and (2) investigate whether HIV infection changes the way opioid treatment affects the ability to think and reason. 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 2 and 4 months compared to baseline; and (2) HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 2 and 4 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants.

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Methadone Methadone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:

Global Neurocognitive Function [ Time Frame: 2 and 4 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: 2 and 4 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 4 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 4 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 (Adult, Senior)
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
Fordham University	Recruiting
Bronx, New York, United States, 10458
Principal Investigator: Monica G. Rivera-Mindt, PhD
Albert Einstein College of Medicine of Yeshiva University	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

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Institute on Drug Abuse (NIDA)

Montefiore Medical Center

Fordham University

More Information


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:	August 4, 2016
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 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 Substance-Related Disorders Chemically-Induced Disorders Mental Disorders	Buprenorphine Methadone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Antitussive Agents Respiratory System Agents

ClinicalTrials.gov processed this record on September 26, 2016

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