Combined Behavioral and Analgesic Trial for Fibromyalgia

Fibromyalgia Clinical Trial

— COMBAT-FM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598753
• Other study ID #: STUDY00001259
• Status: Completed
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).