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:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT01210066
Eligibility Criteria:
Inclusion criteria:
* male and non-pregnant female, non-smoking adults in good general health
* between the ages of 21-40 years old
* fluent in English with willingness to participate in the research study
Supplementary Inclusion Criteria: Prescription Opioid Abusers
* DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
* compliance in treatment and on a stable dose of buprenorphine (6-24mg/day) x at least 10 days prior to screening
* Participation in an ISAP treatment program or a qualified community-based opioid treatment program or private clinic for the entire duration of their study participation
Exclusion criteria:
* regular use of any medication that influences immune status or immune system function
* regular use of a medication that influences pain perception, including opioids (\* only for healthy subjects population\*)
* Regular use of a medication that influences pain perception, except for buprenorphine (\*\* only for POA population\*\*)
* known hypersensitivity to opioids or no previous opioid exposure (\*only healthy controls)
* presence of acute or chronic pain syndrome
* neuropsychiatric illness (i.e., peripheral neuropathy, schizophrenia) known to affect pain perception
* presence of chronic immune compromise (hepatitis C, HIV) or acute infection within the last four weeks
* current or past history of high blood pressure, heart disease, or stroke, or currently have a pacemaker.
* current DSM-IV diagnosis
* BMI less than 18.5 or greater than 29.9
* History of sleep apnea
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT01210066
Study Brief:
Protocol Section:
NCT01210066