Combined Behavioral and Analgesic Trial for Fibromyalgia

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Treatments: Tramadol

Criteria

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