Women's Health and Pain Study

OPEN to enrollment

Evaluate how the use of opioid pain medications impacts physical and mental health.

Overview

One of the common approaches to treat chronic pain is to take opioid pain medication. Research has shown that using opioid pain medication can lower sex hormones in men. Women are understudied in this area, and the extent of opioid pain medication impacting sex hormones in women with chronic pain is not well understood. Changes in sex hormones are also known to influence bone and mental health. It is important to know the health consequences of opioid pain medications so we can develop pain management strategies that are safe and effective for women.

The purpose of this project is to evaluate how using opioid pain medications impacts sex hormones, bone health, and mood in women with chronic pain.

In this study, we will recruit a total of 30 adult women under age 40; 15 of them will have been regularly taking opioid pain medication to treat pain for at least one year, the other 15 will not have taken opioid pain medications. The participants will be asked to have at least one virtual/phone visit and one in-person visit to the study center, and conduct home urine ovulation tests for 7 days.

Your study participation involves completing:

• A virtual consenting visit
• A bone density scan
• A blood draw for sex-hormone levels
• Questionnaires
• Home ovulation testing (1 week)

Study visits are free of charge, and you will be compensated $50 for your time upon completing the study.

Contact

Principle Investigator: Akiko Okifuji, PhD
Department: Anesthesiology, Pain Research Center

Co-Investigator: Christina Bokat, MD

For more information about whether you qualify to participate in this trial, please contact the study coordinator(s) listed below.

Name: Natalie Bennion, MPH
Phone: (571) 585-8111
Email: Natalie.Bennion@utah.edu

Name: Reiko Mitsunaga, RN
Phone: (801) 585-7695
Email: pain.research@hsc.utah.edu

Criteria

In order to be included in this study:

Inclusion Criteria

All patients must be current patients of the University of Utah Pain Management Center (PMC).

• Age: Women under 40
• Regular menstrual cycles
  • Defined as cycle-to-cycle to be ±2 days
• Not taking hormonal-based contraception (Drug eluding IUD is okay) 
• No recent opioid use 
  • Defined as no opioid use in the past year and have not used opioid > 2 weeks in the past 3 years 

• Chronic opioid use 
  • Defined as stable dose of at least 20mg morphine equivalent dose for at least 6 months (if unsure, we can help with this calculation)

Exclusion Criteria

Participant are excluded if they meet any of the criteria listed below:

Presence of: 

• Autoimmune disease (rheumatoid arthritis, lupus) 
• Pregnancy 
• Use of tricycles greater than 75mg amitriptyline or equivalent 
• Use of valproate 
• Use of corticosteroids 
• Resting systolic blood pressure >200mmHG 
• Resting diastolic blood pressure >115mmHG 
• Serious progressive medical disease (e.g., cancer, Parkinson’s) 
• Current use of cannabis (< 4 weeks since last use) or recreational drugs 
• Fracture in the past 12 months 
• Have implantable device 
• Heart catheterization in the past 12 months 
• CT or fluoroscopy guided procedure in the past 6 months 
• Serious psychopathology (psychosis, mania) or active suicidal ideation 

If you are interested, use this link (https://redcap.link/2p4ielvb) :