Neurocognitive Effects of Opiate Agonist Treatment
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 68 |
| Updated: | 7/7/2017 |
| Start Date: | January 2013 |
| End Date: | June 2017 |
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.
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.
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
We found this trial at
2
sites
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1300 Morris Park Avenue
The Bronx, New York 10461
The Bronx, New York 10461
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