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Fungi and Spondyloarthritis Study

The Oregon Health & Science University under the direction of Dr. James Rosenbaum is recruiting patients with spondyloarthritis for an experimental study on the efficacy of terbinafine anti-fungal oral tablets for the treatment of their joint disease. Topical terbinafine ointment is available without a prescription and used to treat fingernail and toenail fungus. Oral terbinafine is only available with a prescription and used to treat more persistent or severe fungal infections. There are data to support the idea that fungi might activate the immune system to contribute to spondyloarthritis.

Study design:

The design of this study is double blind, cross over and it lasts 32 weeks. This means that half of the subjects will start out with a placebo and half will start out on terbinafine. The dose of terbinafine will be 500 mg/day which is twice what is recommended for prescription use. After 16 weeks, those who began with placebo will be switched to terbinafine and those who started with terbinafine will be switched to placebo. During the study, neither the study team nor the subject will know whether terbinafine or placebo is being prescribed. The medicine will be provided without cost.

Who is eligible to take part?

To be eligible for this study, you must:
• Be at least 18 years old.
• Be able to provide records from a physician to confirm the diagnosis of spondyloarthritis
(ankylosing spondylitis, non-radiographic axial spondyloarthritis, psoriatic arthritis, or arthritis secondary to inflammatory bowel disease).
• Not be pregnant or nursing and you must not plan to become pregnant during the 32 weeks of study.
• Not have taken any antibiotics within 3 months of starting the study.
• Agree to remain on a stable treatment regimen for your joint disease for the duration of the trial and for one month before the study begins. You can continue to take your regular medicines for spondylitis in addition to the terbinafine.
• Be willing to complete a questionnaire called the BASDAI about the severity of your disease at multiple time points throughout the study.
• Be willing to undergo blood draws throughout the study to be sure that the medicine is safe. Your insurance will be billed for routine lab tests, but the study will cover costs not
provided by insurance. These blood draws can be done at any outpatient clinical laboratory near you.
• Be willing to provide stool samples by mail. These samples will be analyzed to be sure that the medicine is killing any yeast or fungi which are normally present in stool. You will be provided instructions, collection supplies and shipping materials.

There are additional criteria in order to be eligible such as having no history of cancer, no blood
problems, and no allergy to terbinafine.

Contact:

If you would like to participate in this study, please call 503-494-5070 . A study coordinator will
review all of the eligibility criteria with you and provide information about the laboratory
testing that needs to be done to verify your eligibility and the records that need to be provided.
They can also answer any questions regarding study participation. Although the study is
directed from Oregon, you can participate from anywhere in North America without needing to
visit Oregon.

IRB approval: #21565

Living in Full Even with Pain Study

Do you have chronic pain and regularly take opioid medications? Participate in the Living in Full Even with Pain Study with the University of Washington and get free, evidence-based treatment for pain. We are recruiting from across the entire United States.

Chronic pain is a significant problem affecting millions of Americans. Different types of treatment such as mindfulness meditation, cognitive therapy, and activation skills have been used to treat chronic pain in the general population with success, but little is known as to how these treatments work. The purpose of this study is to compare how these treatments work and see why these treatments are effective. In addition, we are interested in learning whether these treatments allow people to become less reliant on pain medications. This study will use videoconferencing, survey, and activity monitoring technologies.

WHAT DOES PARTICIPATION LOOK LIKE?

  1. Attending videoconferencing group treatment sessions that last about 90 minutes each, on average twice per week for approximately 4 weeks (8 sessions total);
  2. Wearing an activity monitor (similar to a wrist watch) daily for approximately 10 weeks;
  3. Twice daily online surveys for approximately 10 weeks;
  4. Weekly telephone assessments for approximately 10 weeks; and
  5. Four interviews before and after treatment (two via telephone and two online versions).

IMPORTANT: All study procedures are done remotely, from your own home, over the phone or Internet. There are NO in-person procedures. All three treatments are evidence-based and have been shown to benefit those with chronic pain.

Participation in the study will last approximately 8-9 months, with the majority of procedures to occur in the first 3-4 months. Compensation for completion of the phone assessments and online surveys, and the return of the activity monitor, will be provided.

Study design:
Three-group parallel design, randomized controlled clinical trial.

Who is eligible to take part?
You may be eligible to participate if you:

  1. Are 18 years of age or older;
  2. Experience moderate to severe chronic pain on a regular basis;
  3. Are currently taking OPIOID medications on a regular basis;
  4. Are able to read, speak, and understand English; and
  5. Have access to the Internet and a device with a webcam and microphone.

Other eligibility criteria apply. Please contact our study (info below) for more information. All interested participants will need to complete a phone screening to determine eligibility for this study.

Contact:
Phone: 206-221-7224 or toll-free 1-800-570-5576
Email: lifestudy@uw.edu
Website: https://sites.uw.edu/lifestudy/

IRB approval: #STUDY00006474

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