Combined Behavioral and Analgesic Trial for Fibromyalgia (COMBAT-FM)
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|ClinicalTrials.gov Identifier: NCT01598753|
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : November 1, 2018
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:
- Tramadol + CBT,
- Tramadol + HE,
- Placebo + CBT,
- 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 or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Tramadol Drug: Placebo Behavioral: Cognitive Behavior Therapy for FM Behavioral: Health Education||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||228 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
|Active Comparator: 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||
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
- 30% improvement in daily diary pain intensity ratings or 20% improvement in the 9-item function subscale of the Fibromyalgia Impact Questionnaire Revised (FIQR). [ Time Frame: Baseline is one week prior to drug titration. Post treatment is assessed the week following final treatment ]The primary outcome is the change in pain severity measured by the average of 5-days of daily pain diaries, or a change in score of the function subscale of the FIQR, assessed just prior to and at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598753
|United States, New York|
|University of Rochester|
|Rochester, New York, United States|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|