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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT00153192
Eligibility Criteria:
Inclusion Criteria:
* Chronic somatic nociceptive pain syndromes\*, with a minimum pain score on average of 4/10
* Stable doses of opioid analgesics per investigator judgment
* Negative urine pregnancy test in all females with reproductive capacity
* Patients agree to use adequate birth control measures during the study
(\*including but not limited to, musculoskeletal pain, neck pain, low back pain, pain due to osteoarthritis, fibromyalgia, failed back surgery syndrome etc.)
Exclusion Criteria:
* Current substance abuse by self-report.
* Chronic pain due to cancer
* Any marijuana use within three months by self-report
* Active litigation, compensation, or disability issues
* Significant baseline nausea, vomiting, sedation, or other symptoms that may compromise the collection of study-related data
* Patients on a baseline opioid regimen that requires opioid dosing more frequently than every 8 hours
* Unstable psychiatric disorders per investigator judgment
* Baseline Beck depression inventory indicating moderate or greater depression, or active suicidality
* Baseline anxiety inventory indicating moderate or greater anxiety
* Patient feels unable to defer morning opioid dose until arrival in the study center
* Patients using Duragesic patch
* Patients receiving opioids via an implanted intrathecal pump
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00153192
Study Brief:
Protocol Section:
NCT00153192