| City: |
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Indianapolis |
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State:
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IN |
| Zip Code: |
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46202 |
| Conditions: |
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Fibromyalgia |
| Purpose: |
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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).
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Clinical Research Center for Pain, 250 University Blvd
Indianapolis, IN 46202
United States
Primary Contact:
Janna K Hilligoss
Email: jhilligo@iupui.edu
Phone: 317-274-1755
Secondary Contact:
Janna K Hilligoss
Email: jhilligo@iupui.edu
Phone: 317- 274-1755 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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