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:

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 Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Tramadol; Drug: Placebo; Behavioral: Cognitive Behavior Therapy for FM; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States
      • University of Rochester
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University of Washington

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: STUDY00001259