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:
NCT01693692
Eligibility Criteria:
Inclusion Criteria:
* • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
* Informed consent
* 18 to 65 years of age
* Discontinue therapy with adrenergic-acting drugs, and certain other medications
* Only acetaminophen or NSAID as rescue pain medication
* No narcotic pain meds or benzodiazepines
* Only non-benzodiazepines as rescue hypnotics
Exclusion Criteria:
* Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
* Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
* Risk of suicide (investigator opinion and/or C-SSRS)
* Recent history of substance or alcohol abuse
* BMI \<18 or ≥45
* Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
* Abnormal lab values (liver, kidney, thyroid, and others)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01693692
Study Brief:
Protocol Section:
NCT01693692