Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder

Anxiety Clinical Trial

Official title: Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder

Status Recruiting

Clinical Trial Summary

This is a clinical trial evaluating anxiety reduction for women with opioid use disorder affecting pregnancy. It is well documented that anxiety increases as pregnancy progresses. We hypothesize that women who undergo green light therapy (experimental arm) will have a smaller increase in anxiety scores compared to the women who undergo white light therapy (control arm).

We will also look at how much opiate replacement therapy increases women require during the study period, and how much opiate they require during admission for delivery. We think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population. We believe based on animal studies that this could be effective, and change the way we treat and support individuals with substance use disorder.

The opioid epidemic has negatively impacted our society at many levels. Finding non-pharmacologic ways to support patients while in recovery/sustained sobriety that are simple and low cost would be a step forward in providing compassionate and comprehensive treatment to individuals affected by Opioid Use Disorder.

Clinical Trial Description

At time of enrollment, participants will be administered a States-Traits Anxiety Inventory (STAI) questionnaire, undergo screening for ACE score (adverse childhood experiences), and will be asked about basic demographic data. After they complete the initial surveys, the patient will be assigned to either the control group or the experimental group. They will be sent home with the light, along with instructions to use their light every night for 1-2 hours as ambient lighting. We hope to enroll a maximum of 26 patients in this study with 1:1 randomization (13 control, 13 experiment).

At approximately halfway through the intervention, the PI will call the patient and ask how often she has been using the light, how long she uses the light for every night, and whether she has noticed any effects (either positive or negative).

At the prenatal visit around 36 weeks gestation or at time of delivery, whichever is sooner, patients will be asked by the PI to turn in their light and also fill out the STAI once again.

After delivery, the PI will review the medical record and record any change in opioid replacement therapy during pregnancy as well as the total dose of opiate required during the inpatient admission for delivery.

We hope to enroll a maximum of 26 patients in this study with 1:1 randomization (13 control, 13 experiment) ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

• NCT number: NCT04776616
• Study type: Interventional
• Source: University of Arizona
• Contact: Heather L Miller, M.D.
• Phone: 520-626-6636
• Email: hlmiller@obgyn.arizona.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2021
• Completion date: June 30, 2022