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Completed

NCT Number: NCT04776616

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

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. The investigators 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).

The investigators 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. The investigators think this a is a low risk intervention in a pregnant population that has higher levels of anxiety when compared to the general population. The investigators believe based on animal studies that this could be effective, and change the way providers 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.

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Key information

Conditions

Anxiety Anxiety Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banner North Clinic, Obstetrics & Gynecology Clinic

Tucson, Arizona, 85719, United States

About this study

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. The investigators 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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to white LED light

Device

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

Exposure to green LED light

Device

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

Primary outcomes

  1. Change in anxiety over course of intervention, measured by STAI

    Time frame: 4-16 weeks

    The participants will be given a States-Traits Anxiety Inventory (STAI) questionnaire at time of enrollment and then again at time of completion. Score range is 20 to 80, with higher scores indicating greater anxiety.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2021
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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