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

Primary Purpose

Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure to white LED light
Exposure to green LED light
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Pregnancy, Opioid Use Disorder, ACE, STAI

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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:

  1. Inability to speak or understand English
  2. Incarcerated individuals
  3. Age <18 yo

Sites / Locations

  • Banner North Clinic, Obstetrics & Gynecology ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Exposure to white LED light

Exposure to green LED light

Arm Description

Participants will be exposed to white LED strip lights in a dark room for 2 hours a day

Participants will be exposed to green LED strip lights in a dark room for 2 hours a day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Opiate used during admission for delivery
The participants total dose of opiate administered during the admission for delivery will be recorded.

Full Information

First Posted
February 25, 2021
Last Updated
February 25, 2021
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT04776616
Brief Title
Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder
Official Title
Green Light Therapy As a Non-Pharmacologic Intervention to Decrease Anxiety in Pregnant Women With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Pregnancy, Opioid Use Disorder, ACE, STAI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a pilot randomized controlled trial with 1:1 control and intervention
Masking
Participant
Masking Description
Participants will choose a piece of folded paper from a container. This piece of paper will indicate whether they are receiving the control or the experimental intervention.
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure to white LED light
Arm Type
Sham Comparator
Arm Description
Participants will be exposed to white LED strip lights in a dark room for 2 hours a day
Arm Title
Exposure to green LED light
Arm Type
Experimental
Arm Description
Participants will be exposed to green LED strip lights in a dark room for 2 hours a day.
Intervention Type
Device
Intervention Name(s)
Exposure to white LED light
Intervention Description
Participants will be exposed to white LED strip lights in a dark room for 2 hours a day
Intervention Type
Device
Intervention Name(s)
Exposure to green LED light
Intervention Description
Participants will be exposed to green LED strip lights in a dark room for 2 hours a day
Primary Outcome Measure Information:
Title
Change in anxiety over course of intervention, measured by STAI
Description
The participants will be given and STAI at time of enrollment and then again at time of completion.
Time Frame
4-16 weeks
Secondary Outcome Measure Information:
Title
Change in Opiate Replacement Therapy
Description
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.
Time Frame
4-20 weeks
Title
Opiate used during admission for delivery
Description
The participants total dose of opiate administered during the admission for delivery will be recorded.
Time Frame
1-7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather L Miller, M.D.
Phone
520-626-6636
Email
hlmiller@obgyn.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Reed, MD
Phone
520-626-6636
Email
kreed@obgyn.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Miller, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner North Clinic, Obstetrics & Gynecology Clinic
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Miller, M.D.
Phone
520-626-6636
Email
hlmiller@obgyn.arizon.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28092651
Citation
Ibrahim MM, Patwardhan A, Gilbraith KB, Moutal A, Yang X, Chew LA, Largent-Milnes T, Malan TP, Vanderah TW, Porreca F, Khanna R. Long-lasting antinociceptive effects of green light in acute and chronic pain in rats. Pain. 2017 Feb;158(2):347-360. doi: 10.1097/j.pain.0000000000000767.
Results Reference
background
PubMed Identifier
23617869
Citation
Gros DF, Milanak ME, Brady KT, Back SE. Frequency and severity of comorbid mood and anxiety disorders in prescription opioid dependence. Am J Addict. 2013 May-Jun;22(3):261-5. doi: 10.1111/j.1521-0391.2012.12008.x.
Results Reference
background
PubMed Identifier
30928567
Citation
Ecker J, Abuhamad A, Hill W, Bailit J, Bateman BT, Berghella V, Blake-Lamb T, Guille C, Landau R, Minkoff H, Prabhu M, Rosenthal E, Terplan M, Wright TE, Yonkers KA. Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine. Am J Obstet Gynecol. 2019 Jul;221(1):B5-B28. doi: 10.1016/j.ajog.2019.03.022. Epub 2019 Mar 27. No abstract available.
Results Reference
background
PubMed Identifier
22959685
Citation
Newham JJ, Westwood M, Aplin JD, Wittkowski A. State-trait anxiety inventory (STAI) scores during pregnancy following intervention with complementary therapies. J Affect Disord. 2012 Dec 15;142(1-3):22-30. doi: 10.1016/j.jad.2012.04.027. Epub 2012 Sep 7.
Results Reference
background
PubMed Identifier
12612237
Citation
Dube SR, Felitti VJ, Dong M, Chapman DP, Giles WH, Anda RF. Childhood abuse, neglect, and household dysfunction and the risk of illicit drug use: the adverse childhood experiences study. Pediatrics. 2003 Mar;111(3):564-72. doi: 10.1542/peds.111.3.564.
Results Reference
background
PubMed Identifier
18533034
Citation
Anda RF, Brown DW, Felitti VJ, Dube SR, Giles WH. Adverse childhood experiences and prescription drug use in a cohort study of adult HMO patients. BMC Public Health. 2008 Jun 4;8:198. doi: 10.1186/1471-2458-8-198.
Results Reference
background
PubMed Identifier
28841495
Citation
Stein MD, Conti MT, Kenney S, Anderson BJ, Flori JN, Risi MM, Bailey GL. Adverse childhood experience effects on opioid use initiation, injection drug use, and overdose among persons with opioid use disorder. Drug Alcohol Depend. 2017 Oct 1;179:325-329. doi: 10.1016/j.drugalcdep.2017.07.007. Epub 2017 Aug 5.
Results Reference
background
Links:
URL
https://www.cdc.gov/violenceprevention/aces/resources.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fviolenceprevention%2Facestudy%2Fresources.html
Description
CDC Adverse Childhood Experiences Resources

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

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