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

NCT04776616 | Completed DMC

• 1 other identifier: 2011231501
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Anxiety

Keywords

Pregnancy; Opioid Use Disorder; ACE; STAI

Outcome Measures

Primary Outcomes (1)

• Change in anxiety over course of intervention, measured by STAI

  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.

  4-16 weeks

Secondary Outcomes (2)

• Change in Opiate Replacement Therapy

  4-20 weeks

• Opiate used during admission for delivery

  1-7 days

Study Arms (2)

Exposure to white LED light

SHAM COMPARATOR

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

Device: Exposure to white LED light

Exposure to green LED light

EXPERIMENTAL

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

Device: Exposure to green LED light

Interventions

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 white LED light

Exposure to green LED light DEVICE

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

Exposure to green LED light

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability to speak or understand English
• Incarcerated individuals
• Age \<18 yo

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner North Clinic, Obstetrics & Gynecology Clinic

Tucson, Arizona, 85719, United States

Location

Related Publications (7)

• 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.

  PMID: 28092651 BACKGROUND

• 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.

  PMID: 23617869 BACKGROUND

• 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.

  PMID: 30928567 BACKGROUND

• 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.

  PMID: 22959685 BACKGROUND

• 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.

  PMID: 12612237 BACKGROUND

• 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.

  PMID: 18533034 BACKGROUND

• 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.

  PMID: 28841495 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Heather Miller, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot randomized controlled trial with 1:1 control and intervention

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 2, 2021
• Study Start: February 24, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 26, 2024

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)