Drug and Talk Therapy for Fibromyalgia

This study is currently recruiting participants.
Verified by Indiana University, May 2010
First Received: December 18, 2009 Last Updated: November 17, 2010

Sponsor:
Indiana University
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01038323

Purpose
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).

Condition Intervention Phase
Fibromyalgia Other: CBT and milnacipran Behavioral: CBT with a placebo Drug: Educational with milnacipran Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Dose Comparison
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Combined Use of Cognitive Behavioral Therapy (CBT) and Milnacipra

Further study details as provided by Indiana University:
Primary Outcome Measures:

  • Primary analysis: Specific Aim: To estimate effect sizes for each of the three treatment conditions on each of the four outcome measures (i.e., self-report pain severity and physical function, pain-related beliefs and coping and evoked pain sensitivity). [ Time Frame: Baseline, Week 9, and Week 21clinic visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • To test the success of blinding, we will ask all subjects to identify their treatment group and will use McNemar's test to assess the strength of agreement between true assignment and correct answers. [ Time Frame: Baseline, Week 9, and Week 21 clinic visits ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: December 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

CBT and milnacipran: Experimental
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. Intervention: Other: CBT and milnacipran

 

 

 

 

 

 

Other: CBT and milnacipran
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. Other Names:

  • milnacipran
  • Savella
  • Cognitive Behavioral Therapy
  • CBT * fibromyalgia

 

 

CBT and placebo: Placebo
Comparator 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. Intervention: Behavioral: CBT with a placebo

 

 

 

 

 

Behavioral: CBT with a placebo
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. Other Names:

  • placebo
  • sugar pills
  • Cognitive Behavioral Therapy
  • CBT
  • fibromyalgia

 

Educational with milnacipran: Active
Comparator Subjects randomized to this group will receive a series of eight educational phone calls regarding fibromyalgia along with a 21-week regimen of milnacipran. Intervention: Drug: Educational with milnacipran

 

 

 

 

Drug: Educational with milnacipran
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 Names:

  • fibromyalgia
  • fibromyalgia education
  • milnacipran
  • Savella

Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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.

SHOW MAIN MENU
SHOW SUB MENU