Propranolol for Treating Fibromyalgia Pain

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study to evaluate the feasibility of using low dose propranolol for people with fibromyalgia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• Females with fibromyalgia (both meeting 1990 American College of Rheumatology (ACR) FMS criteria and 2010 ACR FMS criteria) age 18-65 with at least 1 year of symptoms and sedentary (exercising less than 120 min per week).

Exclusion Criteria:

• General Health Criteria:

• Uncontrolled/unstable illnesses (physician diagnosed, self-report)

• Pregnancy or planning to be pregnant in the next year

• Having Asthma requiring medication treatment including inhaler

• Type I diabetes or Type II diabetes requiring medical therapy that can lead to hypoglycemia

• Having acute pain or neuropathic pain

• Participation in exercise or psychological treatment studies in the past 2 years

• Having known serious psychopathology: Psychosis, history of inpatient psychiatric admission in the past year, active suicidal intent, history of self-injurious behaviors in the past year, history of recreational IV drug use, substance abuse history in the past year)

• Cardiovascular Criteria:

• Having known cardiovascular diseases (self-report, physician diagnosed)

• Pacemaker

• Bradycardia (resting heartrate of less than 55 bpm)

• Resting diastolic BP < 55 mmHG or systolic BP<100 mmHG

• ECG showing prolonged PR interval > .2 sec

• ECG showing irregular PR interval

• ECG showing incongruence between P wave and QRS

• Medication Criteria

• Allergy or intolerance of beta blockers

• Current use of the following drugs:

• Antihypertensive drugs

• Neuroleptics

• Monoamine oxidase inhibitors

• Tizanidine

• Amphetamine-based medications

• Bupropion

• Mirtazapine

• Tricyclics: daily dose greater than 75mg amitriptyline or equivalent

• Benzodiazepine: daily dose greater than 5mg diazepam or equivalent

• Asthmatic medicine, including inhaler

• Participants may be included after minimum of 4 weeks of physician prescribed termination of these drugs