Combined Behavioral and Analgesic Trial for Fibromyalgia

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