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
1 other identifier
interventional
134
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedResults Posted
Study results publicly available
June 26, 2019
CompletedJune 26, 2019
June 1, 2019
6.3 years
May 1, 2012
June 3, 2019
June 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Study Arms (4)
Tramadol
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORCognitive Behavior Therapy for FM
ACTIVE COMPARATORHealth Education
SHAM COMPARATORInterventions
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
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Eligibility Criteria
You may qualify if:
- Males and Females 21-70
- Diagnosis of Fibromyalgia
- Current primary care physician
- Fluent in English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Rochester
Rochester, New York, United States
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dennis C. Turk, Ph.D.
- Organization
- University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Anesthesiology
Study Record Dates
First Submitted
May 1, 2012
First Posted
May 15, 2012
Study Start
May 1, 2012
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
June 26, 2019
Results First Posted
June 26, 2019
Record last verified: 2019-06