Drug and Talk Therapy for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: CBT and milnacipran; CBT with a placebo; Educational with milnacipran
Intervention description: Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week "starter pack". Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.; Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of a placebo. Dosing for the placebo begins with a one week "starter pack". Dosage: 12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.; Participants will receive a series of eight telephone sessions of fibromyalgia related education along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week "starter pack". Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibromyalgia; FMS

Summary:

      Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and
      societal costs in terms of quality of life, social and work functioning, health care use, and
      lost productivity. Although single therapy approaches such as medication, graduated exercise,
      and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the
      majority of FMS continue to report significant levels of pain and pain-related disability.
      Testing the efficacy of using combination therapies such and CBT with medication has
      considerable potential to maximize treatment response. Also, exploring the biological and
      psychological mechanisms underlying combination treatment may pave the way for developing new
      treatments for FMS sufferers.

      We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate
      medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment
      arm in a study that has both time and budgetary constraints, 3) the complexity in
      understanding the mechanism of actions of 3 different modes of intervention in one clinical
      trial, and 4) the desire to explore mechanisms in this program of research, in particular the
      potential effects of a biological intervention (drug) on what is traditionally considered a
      psychological outcome (pain-related attributions and cognition) and the potential effects of
      a psychological intervention (CBT) on what is traditionally considered a physiological
      outcome (pain sensitivity).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be between the ages of 18 to 65 years of age

          2. Must have been diagnosed with fibromyalgia by a rheumatologist

          3. Must have an overall body pain average score ≥ 4

          4. Must be on stable doses of your current medication for at least past four weeks

          5. Must report all medication including herbal supplements and over-the-counter
             medications that you are currently taking to a member of the research team.

          6. Must limit any changes in your medication(s)during the 21-week study time period
             unless medically necessary

          7. Must be willing to maintain a medication diary provided to you during the 21-week
             study period

          8. 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)

          9. Must experience the symptoms of fibromyalgia syndrome (FMS) that decreases (limits)
             your ability to perform daily activities.

        Exclusions Criteria:

          1. You have uncontrolled hypertension(high blood pressure) systolic >160 mm Hg or
             diastolic blood pressure > 100 mm Hg)

          2. If you have a history of: heart disease, glaucoma, or hepatitis

          3. You have been diagnosed with any type of peripheral neuropathy

          4. You have a body mass index (BMI) of more than 34

          5. You currently or frequently have thoughts of harming yourself or committing suicide.

          6. You are in the process of filing, or plan to file for disability benefits within the
             study timeline.

          7. You plan to undergo an elective surgery within the study timeline.

          8. You have been diagnosed with another major rheumatic conditions (i.e. rheumatoid
             arthritis, systemic lupus erythematosus, scleroderma and other connective tissue
             diseases)

          9. You are currently pregnant, are planning to become pregnant, or are breastfeeding

         10. You have been diagnosed with schizophrenia or manic-depressive.

         11. You are currently taking any of the following medications:

               1. fluoxetine, Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem

               2. sertraline, Brand Name: Zoloft

               3. paroxetine, Brand Names: Paxil, Paxil CR, Pexeva

               4. citalopram, Brand Name: Celexa

               5. escitalopram, Brand Names: Lexapro

               6. venlafaxine, Brand Names: Effexor, Effexor XR

               7. mirtazapine, Brand Names: Remeron, Remeron SolTab

               8. 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.

         12. If you are currently taking or have ever taken Savella® (milnacipran)

         13. 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

         14. 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.