Trial record 51 of 127 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Washington
Information provided by (Responsible Party):
Dennis Turk, University of Washington Identifier:
First received: May 1, 2012
Last updated: June 6, 2014
Last verified: June 2013

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.

Condition Intervention Phase
Drug: Tramadol
Drug: Placebo
Behavioral: Cognitive Behavior Therapy for FM
Behavioral: Health Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Double Blind Randomized Study Comparing Drug Treatment (Tramadol Versus Placebo) and Behavioral Health Treatments (Cognitive Behavior Therapy Versus Health Education)for Patients With Fibromyalgia

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in mean pain severity derived from 5-days of daily pain diaries and change in physical function assessed from the Fibromyalgia Impact Questionnaire-Revised (FIQ-R). [ Time Frame: Baseline is one week prior to drug titration. Post treatment is assessed the week following final treatment ] [ Designated as safety issue: No ]
    The primary outcome is the change in pain severity measured by the average of 5-days of daily pain diaries assessed just prior to and at the end of treatment.

Estimated Enrollment: 250
Study Start Date: May 2012
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Placebo Comparator: Placebo Drug: Placebo
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
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


Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01598753

Contact: Caitlin Sheffels 206-221-1737

United States, New York
University of Rochester Recruiting
Rochester, New York, United States
Contact: Robert Dworkin, PhD   
Principal Investigator: Robert Dworkin, PhD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Caitlin M Sheffels, BA    206-221-1737   
Principal Investigator: Dennis Turk, PhD         
Sponsors and Collaborators
University of Washington
  More Information

No publications provided

Responsible Party: Dennis Turk, Professor, University of Washington Identifier: NCT01598753     History of Changes
Other Study ID Numbers: 42444-B
Study First Received: May 1, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015