Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01733693
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT01733693
Study Brief:
Protocol Section:
NCT01733693