Neurocognitive Effects of Opiate Agonist Treatment (NEO)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Opioid-Related Disorders; HIV; HIV Infections	Drug: Buprenorphine; Drug: Methadone	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	135 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Neurocognitive Effects of Opiate Agonist Treatment
Study Start Date :	January 2013
Actual Primary Completion Date :	June 2017
Actual Study Completion Date :	June 2017

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Global Neurocognitive Function [ Time Frame: 2 and 4 months ]

   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).

2. 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 ]

   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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 68 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

United States, New York
Fordham University
The Bronx, New York, United States, 10458
Albert Einstein College of Medicine of Yeshiva University
The Bronx, New York, United States, 10467

Sponsors and Collaborators

Albert Einstein College of Medicine, Inc.

National Institute on Drug Abuse (NIDA)

Montefiore Medical Center

Fordham University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Julia H. Arnsten, Principal Investigator, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier:	NCT01733693 History of Changes
Other Study ID Numbers:	2012-433; 1R01DA032552-01A1 ( U.S. NIH Grant/Contract )
First Posted:	November 27, 2012
Last Update Posted:	July 6, 2017
Last Verified:	August 2016

Keywords provided by Julia H. Arnsten, Albert Einstein College of Medicine, Inc.:

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