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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT02945293
Eligibility Criteria:
Inclusion Criteria:
* Age of 35 years old or above
* Mild to moderate pain
* alcohol consumption
* willingness to refrain from taking any sort of pain medication 24 hours prior to study visit as well as refraining from taking sedative-hypnotics, antihistamines, benzodiazepines, sleep aids, NSAIDs/opioid pain medications, alcohol, marijuana
* Cigarette smokers must be willing to refrain from smoking during the all day study visit
Exclusion Criteria:
* current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine)
* abstains from alcohol
* unstable angina or CHF; cerebral vascular accident or recurrent TIAs in the prior 6 months, active cancer requiring current treatment, possible or probable dementia or mild cognitive impairment
* Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication
* History of recreational drug use in the past 1 year, excluding marijuana
* New or increased dose (within last 6 months) of CNS-active medications that may alter neurocognitive and/or psychomotor function: MAO inhibitors, neuroleptics, antidepressants, anticonvulsants, benzodiazepines, sleep aids
* Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin
* Known hypersensitivity to oxycodone and other opioids;
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT02945293
Study Brief:
Protocol Section:
NCT02945293