View Clinical Trial (Medical Research Study)
Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavior Therapy Versus Health Education)for Patients With Fibromyalgia
| City: |
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Seattle |
| State: |
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Washington |
| Zip Code: |
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98195 |
| Conditions: |
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Fibromyalgia |
| Purpose: |
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This is a randomized control study that involves a combination of a drug treatment,
behavioral health, and placebo controls.
Some participants will receive a medication approved by the Food and Drug Administration for
treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive
an inactive pill, called a placebo. There will also be 2 different types of behavioral
health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which
have been recommended for the treatment of patients with FM by the American Pain Society.
There are 4 possible study treatment combinations:
1. Tramadol + CBT,
2. Tramadol + HE,
3. Placebo + CBT,
4. Placebo + HE.
Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there
have been no studies that have evaluated the combination of medication and a behavioral
health treatment. The primary purpose of this study is to compare the benefits of the 4
combinations listed.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Males and Females 21-70
- Diagnosis of Fibromyalgia
- Current primary care physician
- Fluent in English
Exclusion Criteria:
- Rheumatologic disorders
- Drug and alcohol abuse in the past year
- Psychiatric hospitalization in the past 6 months
- Current use of Tramadol
- Certain antidepressant and other pain medications
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| NCT ID: |
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NCT01598753 |
| Primary Contact: |
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Laurie Al-Naser
Phone: 206-221-6851
Email: lalnaser@uw.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Seattle, Washington 98195
United States
Laurie Al-Naser
Phone: 206-221-6851
Email: lalnaser@uw.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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