Overview

Neurocognitive Effects of Opiate Agonist Treatment

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Albert Einstein College of Medicine
Albert Einstein College of Medicine of Yeshiva University
Collaborators:
Fordham University
Montefiore Medical Center
National Institute on Drug Abuse (NIDA)
Treatments:
Buprenorphine
Methadone
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