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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Anxiety

Intervention / Treatment
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* Device: Exposure to white LED light
* Device: Exposure to green LED light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women between 20 - 32 weeks gestation with a diagnosis of opiate use disorder receiving care through Banner University Medical Center North Mothers Over Medicine (MOMs) Clinic, a high-risk pregnancy clinic for women with substance use disorder complicating pregnancy Exclusion Criteria: Inability to speak or understand English Incarcerated individuals Age <18 yo

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot randomized controlled trial with 1:1 control and intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Exposure to white LED light<br>Participants will be exposed to white LED strip lights in a dark room for 2 hours a day | Device: Exposure to white LED light<br>* Participants will be exposed to white LED strip lights in a dark room for 2 hours a day<br>|
| Experimental: Exposure to green LED light<br>Participants will be exposed to green LED strip lights in a dark room for 2 hours a day. | Device: Exposure to green LED light<br>* Participants will be exposed to green LED strip lights in a dark room for 2 hours a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety over course of intervention, measured by STAI | The participants will be given and STAI at time of enrollment and then again at time of completion. | 4-16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opiate Replacement Therapy | The participants dose of opiate replacement therapy will be recorded at time of enrollment, at time of completion of the study, and also at time of delivery if it doesn't coincide with completion of study. | 4-20 weeks | 
| Opiate used during admission for delivery | The participants total dose of opiate administered during the admission for delivery will be recorded. | 1-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACE, Pregnancy, Opioid Use Disorder, STAI