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

February 25, 2021 updated by: Heather Miller, University of Arizona

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner North Clinic, Obstetrics & Gynecology Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety over course of intervention, measured by STAI
Time Frame: 4-16 weeks
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
Time Frame: 4-20 weeks
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
Time Frame: 1-7 days
The participants total dose of opiate administered during the admission for delivery will be recorded.
1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Heather Miller, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011231501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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