Combined Behavioral and Analgesic Trial for Fibromyalgia (COMBAT-FM)

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: Tramadol + CBT, Tramadol + HE, Placebo + CBT, 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.

50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day. Minimum accepted dose of 200mg per day

Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.

The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled "responders."

Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).

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