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

University of Washington

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Tramadol; Behavioral: Cognitive Behavior Therapy for FM; Drug: Placebo; Behavioral: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01598753

STUDY00001259

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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134 participants in 4 patient groups, including a placebo group

Tramadol

Active Comparator group

Treatment:

Drug: Tramadol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Cognitive Behavior Therapy for FM

Active Comparator group

Treatment:

Behavioral: Cognitive Behavior Therapy for FM

Health Education

Sham Comparator group

Treatment:

Behavioral: Health Education