Neurocognitive Effects of Opiate Agonist Treatment

Completed · Phase 4

Conditions studied: Opioid-Related Disorders, HIV, HIV Infections

In brief

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.

Key facts

Study ID

NCT01733693

Run by

Albert Einstein College of Medicine

People needed

135

Starts

2013-01-01

Expected to finish

2017-06-01

Last updated by the study team

2022-02-11

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fordham University — The Bronx, New York, United States
• Albert Einstein College of Medicine of Yeshiva University — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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