At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Tramadol, Placebo, and 2 other interventions for Fibromyalgia. Completed, enrolled 134 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
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
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia