Drug and Talk Therapy for Fibromyalgia
Completed · Phase 4 · Has a placebo group
Conditions studied: Fibromyalgia
In brief
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).
Key facts
- Study ID
- NCT01038323
- Run by
- Indiana University
- People needed
- 58
- Starts
- 2009-12-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2017-03-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Clinical Research Center for Pain, 250 University Blvd — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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