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Completed

NCT Number: NCT01598753

Combined Behavioral and Analgesic Trial for 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Rochester, Rochester, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

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

Drug

Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg

Cognitive Behavior Therapy for FM

Behavioral

Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.

Health Education

Behavioral

Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia

Primary outcomes

  1. Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function

    Time frame: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).

    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."

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Acronym: COMBAT-FM

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
May 15, 2012
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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