Combined Behavioral and Analgesic Trial for Fibromyalgia

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:21 - 70
Start Date:May 2012
End Date:July 31, 2018

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Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavioral Therapy Versus Health Education) for Patients With Fibromyalgia

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.

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
We found this trial at
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Dennis Turk, PhD
Phone: 206-221-1737
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Seattle, WA
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Robert Dworkin, PhD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
Rochester, NY
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