Monday, October 8th, 2012
Fibromyalgia (FM) is a common and disabling disorder. Currently, no single treatment has been found to be totally effective for all who have FM. This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls. If you participate you will be randomly assigned a treatment (like flipping a coin). 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. If you receive the inactive pill, you will receive a capsule similar in appearance to Tramadol HCl IR. 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.
The primary purpose of this study is to compare the benefits of the 4 combinations listed.
If you agree to participate in this study, your primary participation will last 15 weeks with a follow-up visit 6 months after completing treatment. The study consists of 4 phases; Pre-treatment screening (the first 2 visits), Treatment (10 weeks of study medication and 8 one hour behavioral health sessions), Post-treatment evaluation and drug taper (2 visits) and Follow-up (1 visit at 6 months post-treatment). During the follow-up phase, you will also receive a monthly phone call to touch base and at 3 months we will send you a series of questionnaires either electronically or by mail for you to complete and return.
Males or females, age 21-70 with a diagnosis of Fibromyalgia.
Currently have a primary healthcare provider
Not taken Tramadol in the past 6 months
No regular use of opiod medication (fewer than 10 tablets per month)
Fluent in English
University District Building
1107 NE 45th St. Suite 320
Seattle, WA 98105
Up to $300 for the completion of the entire study.
For more information, please contact Caitlin at (206)221-1737 or firstname.lastname@example.org (we cannot guarantee the confidentiality of any information sent by email).