Neurocognitive Effects of Opiate Agonist Treatment (NEO)
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ClinicalTrials.gov Identifier: NCT01733693 |
Recruitment Status
:
Completed
First Posted
: November 27, 2012
Last Update Posted
: July 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opioid-Related Disorders HIV HIV Infections | Drug: Buprenorphine Drug: Methadone | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Buprenorphine
Oral sublingual tablet, 8-32 mg per day, administered daily for duration of 4 months
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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.
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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.
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- 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).
- 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

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Ages Eligible for Study: | 18 Years to 68 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733693
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 |
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 Key Record Dates |
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 |