Drug and Talk Therapy for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

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).
    

Detailed description: 
      Qualified participants will take part in a 21-week clinical research study entitled, "Drug
      and Talk Therapy for Fibromyalgia". We are doing this study to better understand how talk
      therapies, such as education and cognitive behavioral therapy (CBT), can improve the
      therapeutic benefits of drug for fibromyalgia.

      Savella ®, (milnacipran) is an FDA approved drug for fibromyalgia. The safety and efficacy of
      Savella has been established in two US-based clinical studies involving over 2,000 patients
      with fibromyalgia. Because Savella has already been shown to be effective when used in
      isolation to treat fibromyalgia, we are conducting the study to determine whether combination
      treatment (Savella + talk therapy) is more efficacious than just Savella alone or talk
      therapy alone.

      Volunteers will be randomized (like flipping a coin) on two different levels:

        1. Each participate will be randomized into one of two groups for medication:

           One group will receive Savella and the other group will receive a placebo (no medicinal
           value). Both the medication and the placebo will look identical and subjects will not be
           told into which group they have been placed until the completion of the study. Each
           participants has 66% chance of receiving Savella and 34% chance of getting the placebo.

        2. The second level of randomization will be to determine which type of talk therapies you
           will be assigned to. Subjects will be randomly assigned to receive educational
           instruction relevant to fibromyalgia, OR cognitive behavioral therapy which includes a
           workbook. Both talk therapies will be provided over the phone once a week for 8 weeks.
           Each phone session may last for 30 minutes. Importantly, both talk therapies can provide
           coping tools and information designed to help manage fibromyalgia symptoms.

      Study Overview:

      Subjects will be asked to visit the Fibromyalgia Clinical Research Center on five separate
      occasions: Initial Screening (today's visit), Week 1, Week 2, Week 9, and Week 21.

      VISIT 1:

        1. Informed consent and initial screening questionnaire,physical assessment

        2. Issue a 'pain score' wrist monitor with instructions to record current pain level three
           times a day for one week

      VISIT 2:

        1. Submit your pain recording

        2. Complete the self-assessment questionnaires via computer

        3. Vital signs check

        4. Undergo pain sensitivity testing

        5. If qualified, subjects be randomized to receive Savella or placebo AND to receive
           education or cognitive behavioral therapy

      VISIT 3:

        1. We will assess the subject's willingness to continue participation.

        2. Review medication diary and medication side-effect checklist.

        3. Schedule PHONE Therapy sessions: 8 thirty minute calls

      VISIT 4:

        1. One week prior to this visit, subjects will receive a 'pain score' monitor in order to
           enter current pain levels three times a day for one week. Then report for this visit.

        2. Review side effect checklist, medication diary.

        3. Completion of self-assessment questionnaires via computer

        4. Undergo pain sensitivity testing

      VISIT 5:

        1. One week prior to this visit, subjects will receive a 'pain score' monitor in order to
           enter current pain levels three times a day for one week. Then report for this visit.

        2. Review side effect checklist, medication diary.

        3. Completion of self-assessment questionnaires via computer

        4. Undergo pain sensitivity testing

        5. Upon visit completion, participants will receive a reduced dose regimen of the
           medication along with written and verbal instructions to safely discontinue the study
           medication.
    

Intervention name(s): CBT and milnacipran; CBT with a placebo; Educational with milnacipran
Intervention type(s): Other; Behavioral; Drug
Intervention description(s): 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.
Other intervention name(s): milnacipran; Savella; Cognitive Behavioral Therapy; CBT; fibromyalgia; placebo; sugar pills; Cognitive Behavioral Therapy; CBT; fibromyalgia; fibromyalgia; fibromyalgia education; milnacipran; Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; FMS