Neurocognitive Effects of Opiate Agonist Treatment (NEO)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01733693
| Contact: Zohar Massey, MPH | (718) 944-3849 | ZMASSEY@montefiore.org | |
| Contact: Julia H. Arnsten, MD, MPH | (718) 944-3848 | JARNSTEN@montefiore.org |
| 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 | |
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:
|
Opioid-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Buprenorphine Methadone Analgesics Analgesics, Opioid Antitussive Agents Central Nervous System Agents |
Central Nervous System Depressants Narcotic Antagonists Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015