Combined Behavioral and Analgesic Trial for Fibromyalgia

Study Overview
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Brief Summary
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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: 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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Tramadol
* Drug: Placebo
* Behavioral: Cognitive Behavior Therapy for FM
* Behavioral: Health Education


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol<br> | Drug: Tramadol<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg<br>|
| Active Comparator: Cognitive Behavior Therapy for FM<br> | Behavioral: Cognitive Behavior Therapy for FM<br>* Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.<br>|
| Sham Comparator: Health Education<br> | Behavioral: Health Education<br>* Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | 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). |