Drug and Talk Therapy for Fibromyalgia
Fibromyalgia
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, FMS
Eligibility Criteria
Inclusion Criteria:
- Must be between the ages of 18 to 65 years of age
- Must have been diagnosed with fibromyalgia by a rheumatologist
- Must have an overall body pain average score ≥ 4
- Must be on stable doses of your current medication for at least past four weeks
- Must report all medication including herbal supplements and over-the-counter medications that you are currently taking to a member of the research team.
- Must limit any changes in your medication(s)during the 21-week study time period unless medically necessary
- Must be willing to maintain a medication diary provided to you during the 21-week study period
- Must be willing to abstain (not take) any fibromyalgia related medication (including over-the-counter)for at least 6-hours prior to each of the three testing visits. (Otherwise, you may take these medication immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
- Must experience the symptoms of fibromyalgia syndrome (FMS) that decreases (limits) your ability to perform daily activities.
Exclusions Criteria:
- You have uncontrolled hypertension(high blood pressure) systolic >160 mm Hg or diastolic blood pressure > 100 mm Hg)
- If you have a history of: heart disease, glaucoma, or hepatitis
- You have been diagnosed with any type of peripheral neuropathy
- You have a body mass index (BMI) of more than 34
- You currently or frequently have thoughts of harming yourself or committing suicide.
- You are in the process of filing, or plan to file for disability benefits within the study timeline.
- You plan to undergo an elective surgery within the study timeline.
- You have been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue diseases)
- You are currently pregnant, are planning to become pregnant, or are breastfeeding
- You have been diagnosed with schizophrenia or manic-depressive.
You are currently taking any of the following medications:
- fluoxetine, Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem
- sertraline, Brand Name: Zoloft
- paroxetine, Brand Names: Paxil, Paxil CR, Pexeva
- citalopram, Brand Name: Celexa
- escitalopram, Brand Names: Lexapro
- venlafaxine, Brand Names: Effexor, Effexor XR
- mirtazapine, Brand Names: Remeron, Remeron SolTab
- duloxetine, Brand Name: Cymbalta NOTE: If you are taking any of the medication(s) listed above and are willing to discontinue its use for the duration of this study, you must first discuss your decision with your primary care physician (or prescribing doctor)regarding the appropriate regimen to wean off your current medication and receive his/her written consent before proceeding with enrollment. We will provide you a "Dear Doctor" letter that explains the study details.
- If you are currently taking or have ever taken Savella® (milnacipran)
- You are currently participating in other pain research study or have previously been enrolled in any study or class in which cognitive behavioral therapy or educational formats were used to help control pain or stress related to fibromyalgia
- You are unwilling or unable to comply with the study guidelines
Note: If you have ever experienced an adverse event while taking any type of antidepressant, please alert the research team, while it may not exclude you from participating in the study, it is important that we are aware of the incident in order to keep you safe.
Sites / Locations
- Clinical Research Center for Pain, 250 University Blvd
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Active Comparator
CBT and milnacipran
CBT and placebo
Educational with milnacipran
Subjects randomized to this group will receive a combination of eight telephone sessions of Cognitive Behavior Therapy (CBT) and a 21-week regimen of milnacipran.
Subjects randomized to this arm will receive a series of eight telephone sessions of Cognitive Behavioral Therapy (CBT) along with a 21-week regimen of a placebo(sugar pill)medication.
Subjects randomized to this group will receive a series of eight educational phone calls regarding fibromyalgia along with a 21-week regimen of milnacipran.